Cancer Annotation SaMD Manufacturer
A software as a medical device company had just received their 510k clearance and is now on the market selling product. They know the countdown to an FDA audit has started, but they are not exactly sure when the FDA will show up at their doorstep. In order to get ahead of an FDA audit, they were looking for consultants with software experience and experience with the FDA quality system regulation in order to identify gaps in their quality system before the FDA can identify them, thereby reducing the chance of an FDA hold letter which could get them shut down.
We provided an extensive gap analysis that resulted in corrective actions being performed just in time for an FDA audit, it is unlikely that the gap assessment could have been performed during the FDA audit, which the client has passed with very little findings due to our gap analysis and recommendations.
We worked with the client to answer the following questions and identify the path of least resistance for remediation.
| Audit Questions |
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| Is the quality management system documented, implemented and maintained in accordance with requirements of ISO 13485 and CFR 21 Part 820? |
| Is the role undertaken by the organization under the applicable regulatory requirements defined and documented? |
| • Are QMS processes, and the sequence and interraction of these processes determined? • Is risk based approach applied to control of QMS processes |
| For each process of the QMS are there: • defined operational and control criteria; • actions, activities, resources and information required to support the process; • monitoring and measurement programs; • records to demonstrate conformance? |
| Are changes to QMS processes controlled, to include: • evaluation of impacts on the QMS and on the medical devices; • compliance with applicable regulatory requirements; |
| Are outsourced processes adequately controlled? |
| • Is computer software used in the QMS validated? • Is risk management used to ensure that validation is proportionate to the risks associated with the use of the software? |
| Are the following types of documents established, maintained and controlled: • quality policy and quality objectives; • quality manual; • QMS procedures; • documents and records necessary to ensure the effective planning, operation, and control of QMS and other processes; • documents specified by regulatory requirements;? |
| Does the quality manual include: • the scope of the quality management system and exclusions, • operational procedures or references to them, • description of the interaction between the processes of the quality system, and • outline of the structure of the quality system documentation? |
| For each type of device, is there a Medical Device File (in 21 CFR 820 referred to as Device Master Record) including, or referring: • Description of the medical device, uses and labeling; • Product specifications and specifications/procedures for manufacturing, packaging, storage, handling and distribution; • procedures for measuring and monitoring; • requirements/procedures for installation and servicing (as appropriate)? |
| Is there a written procedure defining the controls needed to • review and approve documents prior to issue, • review, update and re-approve documents, • identify changes and current revisions of documents, • make relevant and current documents available at points of use, • ensure that documents are legible and identifiable, • identify and control the distribution of documents of external origin, and • identify retained obsolete documents and prevent their unintended use? Is the procedure fully implemented? |
| Is the period for retention of obsolete controlled documents defined? |
| Are document changes reviewed and approved by the same function that performed the original review and approval (unless specifically designated otherwise)? Are change records maintained, including description of the change, identification of the affected documents, approval signatures and date, and when the change becomes effective? |
| Is there a documented procedure for the identification, storage, protection, retrieval, retention, and disposition of records? |
| Are retention periods for records defined? Are records retained for at least the period of time equivalent to the expected life of the device, and no less than 2 years? |
| Are there defined and implemented methods for protecting confidential health information contained in records? |
| Are records organized and maintained to ensure that they remain legible, readily identifiable and retrievable, and to prevent deterioration and loss? Are records accessible to the regulatory inspections? Are electronic records backed up? |
| Are Device History Records (DHR) maintained for each manufactured batch, lot or unit? (Refer also to ISO 13485 Clause 7.5.1 and 820.184) |
| Are Quality System Records (QSR) maintained, including current and obsolete quality system manuals and procedures, and records of quality system activities such as management reviews, corrective and preventive actions, internal audits, etc.? |
| Are sufficient records maintained to provide evidence of conformity and effectiveness of the quality management system? |
| Is the top management • communicating to the organization the importance of meeting customer and other applicable requirements, • establishing the quality policy, • establishing quality objectives, • conducting management reviews, and • ensuring availability of resources? |
| Is the top management ensuring that customer requirements are determined and are met? |
| Is there a documented quality policy; and • Is it appropriate to the purpose of the organization? • Does it include a commitment to comply with requirements and maintain the effectiveness of the quality management system? • Does it provide a framework for establishing the quality objectives? • Is it communicated and understood throughout the organization? • Is it periodically reviewed for continuing suitability? |
| Are measurable quality objectives established? Are the objectives consistent with the quality policy? |
| Is the quality system planned to meet requirements and quality objectives? Is the integrity of the quality system maintained when changes are implemented? |
| Are responsibilities and authorities defined, and are they communicated throughout the organization? For personnel who manage, perform and verify work affecting quality, is their interrelation defined, and do they have sufficient independence and authority to perform these tasks? |
| Is there a management representative for the quality management system? Are his/her responsibilities defined, to include: • ensuring that processes needed for the quality system are established, implemented and maintained, • reporting to top management on the performance of the quality system and need for improvement, and • promoting the awareness of regulatory and customer requirements? |
| Are appropriate communication processes established within the organization? Are information and data regarding the effectiveness of the quality system regularly communicated? |
| Is the quality management system periodically reviewed to ensure its continuing suitability, adequacy and effectiveness, and to identify opportunities for improvement? |
| Does the input into management reviews include: • feedback and complaints • regulatory reporting • results of audits, • monitoring and measurement of products and processes • corrective and preventive actions, • actions from previous reviews • changes, • recommendations for improvement, and • new or revised regulatory requirements? |
| Does the output from management reviews include decisions and actions related to: • improvements of the quality system and its processes, • improvements of product related to customer requirements, and • changes needed to respond to new regulatory requirements • resource needs? |
| Are adequate resources provided to implement and maintain the quality management system? |
| Are adequate resources provided to meet regulatory and customer requirements? |
| Do personnel performing work affecting product quality have appropriate education, training, skills and experience? Are adequate records of their qualifications maintained? |
| Are competence requirements for personnel defined and training needs identified? Is training provided, or are other actions taken to satisfy the competence requirements? Is the effectiveness of training (or other actions taken) evaluated? |
| Are personnel made aware of the relevance and importance of their work and how they contribute to the achievement of quality objectives? Are personnel made aware of device defects which may occur from the improper performance of their specific jobs? Are personnel who perform verification and validation activities made aware of defects and errors that may be encountered as part of their job functions? |
| Is the needed infrastructure, to include • buildings, workspaces and associated utilities, • manufacturing equipment, and • supporting services, determined, provided and maintained? |
| Are requirements for manufacturing equipment specified? How is it ensured that these requirements are met? |
| Are schedules established for the adjustment, cleaning, and other maintenance of equipment to ensure that manufacturing specifications are met? Are maintenance activities documented, including the date and individuals performing the maintenance activities? |
| Are periodical inspections conducted to ensure adherence to equipment maintenance schedules? Are these inspections recorded, including the date and the names of the individuals conducting the inspection? |
| Where periodic equipment adjustments may be required, are instructions and/or criteria for these adjustments readily available? |
| Are requirements for the work environment determined? Is the environment adequately managed? |
| Requirements in this section apply only when work environment conditions can have an adverse effect on product quality, and the product is not subjected to a cleaning process (ISO 13485 Clause 7.5.1.2.1): Are there documented requirements for the work environment conditions? Are there documented procedures or work instructions to monitor and control these work environment conditions? Are environmental control systems, including related equipment, periodically inspected to verify that they are adequate and functioning properly? Are these activities documented and reviewed? |
| Requirements in this section apply only when contact between personnel and the product or work environment could adversely affect the quality of the product, and the product is not subjected to a cleaning process (ISO 13485 Clause 7.5.1.2.1). Are there documented requirements for health, cleanliness, personal practices, and clothing of personnel? |
| Requirements in this section apply only where there are work areas with special environmental conditions (clean rooms, for example): Are personnel temporarily working under special environmental conditions appropriately trained or supervised by a trained person? |
| Requirements in this section apply only where contaminated product could further contaminate other product, equipment, work environment, or personnel: Are special arrangements implemented for the control of contaminated or potentially contaminated product? Are these arrangements documented? |
| For sterile medical devices, are there documented requirements for control of contamination with microorganisms or particulate matter? Are there requirements for maintaining required cleanliness during assembly and packaging processes? |
| Are product quality objectives and requirements determined? |
| Are production processes developed and established? Are adequate equipment, operators and other resources specific to the product provided? Are adequate infrastructure and work environment provided? |
| Are there defined requirements for verification, validation, monitoring, inspection/test, handling storage, distribution, and traceability activities specific to the product? Are the criteria for product acceptance determined? |
| Are there defined requirements for records needed to provide evidence that production processes and resulting product meet specified requirements? |
| Are there documented requirements for risk management throughout product realization? Are records arising from risk management maintained? |
| Are product requirements defined and documented, and include • requirements specified by the customer (including delivery and post-delivery); • requirements not stated by the customer, but necessary for specified or intended use; • statutory and regulatory requirements related to the product; • any user training needed; and • any additional requirements determined by the company? |
| Prior to the commitment to supply product, are requirements related to the product reviewed to ensure that • requirements are defined, • any discrepancies and ambiguities are resolved, • regulatory requirements are met, • user training is available, • company is able to meet the requirements? Are review records maintained? |
| Where product requirements are not documented (not communicated in writing), are the requirements confirmed before accepting the order? |
| When changing or amending orders, are relevant documents amended, and are the changes communicated to relevant personnel? |
| Are there defined and implemented arrangements for • communicating product information, and • handling enquiries, orders and change orders? |
| Are effective arrangements defined for communicating with customers regarding customer feedback and customer complaints, and advisory notices? |
| Is there evidence of communication with regulatory authorities as required by applicable regulations? |
| Are design and development processes and activities documented in procedures? |
| Are product design activities planned, to include • the design stages; • the review, verification, validation and design transfer activities appropriate to each stage; • assignment of responsibilities and authorities; • methods to ensure traceablity between design inputs and outputs; • resources and competence of personnel? Is the design planning output documented, reviewed and approved, and is it updated as the design progresses? |
| Are design inputs determined and documented, and include, as applicable, • functional, performance, usability and safety requirements according to the intended use and needs of the user, • regulatory requirements, • information from previous similar designs, • outputs of risk management? Are there procedures for addressing incomplete, ambiguous or conflicting design input requirements? Are design inputs reviewed for adequacy and approved by a designated person? |
| Are design outputs provided in a form that is suitable for verification against design input requirements? Are design outputs documented, reviewed, and approved prior to release? |
| Do design outputs • meet design input requirements, • provide necessary information for purchasing and production, • contain acceptance criteria, and • specify product characteristics that are essential for its safe and proper use? |
| Are there design project records (Design History File) demonstrating that design was developed in accordance with the approved design plan and with regulatory and quality system requirements? |
| Are design reviews conducted to evaluate whether the design is on track toward meeting input requirements, and to identify any problems and propose necessary actions? Do participants at each review include all functions concerned, any specialists needed, and a person who does not have direct responsibility for the design stage being reviewed? Are records of the reviews and the resulting actions maintained? |
| Are designs verified to ensure that design outputs have met the design input requirements? Are verification plans documented? Do they include verification methods, acceptance criteria, and rationale for sample sizes? Are records of the verification results and any related actions maintained? |
| Where the device is to be connected to, or have an interface with, other medical devices, does the verification includes cases where the device is when so connected or interfaced? |
| Are designs validated to ensure that the resulting product is capable of meeting the requirements for user needs and intended uses? Are validation plans documented? Do they include validation methods, acceptance criteria, and rationale for sample sizes? Is the validation conducted on representative product? Is there a record of the rationale for the choice of product used for validation? Are records of the validation results and any related actions maintained? |
| Where the device is to be connected to, or have an interface with, other medical devices, does the validation includes cases where the device is when so connected or interfaced? |
| Are there procedures to ensure that the design is correctly translated into production specifications (refer also to ISO 13485 Clause 7.1)? Are design outputs verified as suitable for manufacturing? |
| Are there documented procedures to control design and development changes. Are impacts of change on function, performance, usability, and safety determined? and applicable regulatory requirements Are design changes reviewed, verified, validated, as appropriate, and approved before their implementation? Are changes evaluated with respect to their effect on constituent parts and on product already delivered? Are records of changes maintained, to include their reviews/evaluations and any necessary actions? |
| For each type of device, is there a Design File (in 21 CFR 820 referred to as Design History file) including, or referring: • records generated to demonstrate conformity to the design requirements, • records of design changes? |
| Are suppliers and the supplied product adequately controlled to ensure that the product conforms to specified purchase requirements? |
| Are suppliers evaluated, and is supplier selection based on their ability to provide products conforming to specified requirements? Are supplier evaluation and selection (approval) criteria established? Is there an approved supplier list? Are records or supplier evaluations and related actions maintained? |
| Is supplier performance monitored? Are suppliers re-evaluated, based on their performance? Is non-fulfilment of purchasing requirements addressed with the supplier. Is risk associated with purchased products considered when addressing supplied product nonconformities? |
| Do purchasing specifications include, where appropriate, • product specification, • requirements for approval of product, procedures, processes and equipment; • requirements for approval of personnel, and • quality management system requirements? Do purchasing documents include an agreement obliging suppliers to give notification of changes to their product or service? |
| Are purchasing specifications (data) approved before they are forwarded to suppliers? |
| Are there agreements requiring suppliers to notify of changes in the purchased product that effect the ability to meet purchase requirements? |
| Are there established and implemented activities necessary for ensuring that purchased products meet specified requirements? |
| Is the extent of purchased product verification based on supplier performance and on risk associated with the purchased product? |
| When intending to perform product verification at supplier premises, are verification arrangements and methods defined in the purchasing documents? |
| Are adequate production specifications available, to include, as applicable: procedures, requirements, work instructions, reference materials, and reference measurement procedures? |
| Are suitable production equipment and other infrastructure available? |
| Are suitable monitoring and measuring devices available? Are monitoring and measurement activities implemented? |
| Are operations for labeling and packaging defined and implemented? |
| Are label printing and application methods appropriate to ensure that labels remain legible and affixed during processing, handling, distribution, and where appropriate use? Before releasing labels, are they inspected by designated person to verify their correctness? Is this inspection recorded in the DHR? Are labels stored in a way to provide proper identification and prevent mix-ups? Are labeling operations controlled to prevent mix-ups? Is the labeling used for each unit, lot or batch documented in the DHR? Where a control number is required, is the device identified with the control number throughout distribution? |
| Are release, delivery and post-delivery activities implemented? |
| Is there a procedure for controlling changes to specifications, processes and manufacturing methods? Are such changes verified and approved? |
| Are there Device History Records (Batch Records) for each manufactured batch, lot or unit? Are the following records included in the DHRs: • the date of manufacture, quantity manufactured, and quantity released for distribution; • the acceptance records demonstrating that the device is manufactured in accordance with the DMR; • the primary identification label and labeling used for each production unit; ◦ any device identifications and control numbers used; and • other traceability information to the extent specified? |
| Where applicable, are documented requirements for cleanliness of product established? |
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Applies only where a manufacturing material could have an adverse effect on product quality: Are there procedures for use and removal of such manufacturing material? Is the removal (cleaning) of manufacturing material documented? |
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Applies only to devices requiring installation: Are there adequate installation instructions, to include inspection and test procedures and acceptance criteria for verifying the installation? Are these instructions distributed with the device, or are otherwise made available to persons installing the device? When installation is performed by the organization or its authorized agent, are records of the installation and its verification maintained? |
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Applies only where servicing is a specified requirement: Are there adequate instructions and procedures for performing servicing and for verifying that servicing meets the specified requirements? Are there documented service reports that include: • name and identification (serial number) of the device serviced, • date of service, • identification of the individual servicing the device, • description of the service performed, and • test and inspection data? Are service reports analyzed with appropriate statistical methodology to detect recurring quality problems? When service report represents a reportable event (part 803 or 804), is the report considered as a complaint, and is it processed in accordance with applicable regulatory requirements (820.198)? |
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Applies only to sterilization processes: For each sterilization batch of product, are records of the sterilization process parameters maintained? Are these records traceable to each production batch? |
| Where the results of a production process cannot be fully verified by subsequent inspection and test, are these processes validated? Are validation results documented and approved? Are appropriate arrangements established for these processes, including • criteria for their review and approval, • monitoring and control of process parameters, • personnel qualifications, and • use of specific methods and procedures. Are there process monitoring and control records for these processes, including date, methods, data, equipment, and the process operators? When changes or process deviations occur, are these processes revalidated? Are the results documented and approved? |
| Where computer software is used for production and/or service provision automated processes), are such software applications validated prior to initial use? Are validation results documented? Are all software changes also validated? |
| Is the extent of software validation based on risk associated with the use of the software? |
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Applies only to sterilization processes sterile barrier systems: Are there documented procedures for the validation of sterilization processes? Are sterilization processes validated, and are there validation records for each sterilization process? Are sterilization processes re-validated following product or process changes? |
| Are products suitably identified throughout product realization to prevent mix-ups? Are returned medical devices identified to distinguish them from conforming product? |
| Throughout all product realization stages, are products identified with respect to their acceptance status to indicate the conformity or nonconformity of the product? |
| Are there procedures or specifications defining the extent of product traceability and the records required? |
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Applies only when the device is intended • for surgical implant into the body, • to support or sustain life, and • whose failure could result in significant injury: Are devices (units, lots or batches) and their key components identified with control numbers? Are all production records included in the DHR identified with these control numbers? Do production records (DHR) include records of all components, materials and environmental conditions during production? Are agents and distributors of the device required to maintain distribution records, to include the name and address of the shipping package consignee? Are these records available for inspection? |
| When customer provides product for use or incorporation into the final product, is customer property identified, verified, protected and safeguarded? Are customers notified in any event of loss, damage or unsuitability of their property? |
| Are suitable product handling and preservation methods developed and implemented to prevent mix-ups, damage, deterioration and contamination of product? |
| Are storage areas and stock rooms adequately controlled to prevent mix-ups, damage, deterioration and contamination of product pending use or distribution? |
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Applies only to product with limited shelf-life or requiring special storage conditions: Are products stored in a way to facilitate proper stock rotation? Are storage conditions controlled and recorded? Is the condition of these products periodically assessed? Are there documented procedures for these activities? |
| Are there documented methods for authorizing receipt from and dispatch to storage areas and stock rooms? |
| Are products adequately preserved and protected during processing, storage, handling and delivery to the intended destination. |
| Are distribution records maintained, to include • the name and address of the initial consignee, • the identification and quantity of devices shipped, • the date shipped, and • any control numbers used? |
| Is it determined what monitoring and measurements are to be undertaken and what measuring devices are needed to verify product conformity? |
| Are documented procedures for monitoring and measuring activities established? |
| Are the measuring and monitoring devices • calibrated or verified against traceable measurement standards, • adjusted or re-adjusted as necessary, • identified (also with calibration status), • safeguarded from improper adjustments, and • protected from damage and deterioration? Are calibrations performed in accordance with documented procedures? Are calibration records maintained? Are adjustments and re-adjustments recorded? |
| When a measuring device is found to be nonconforming (damaged, out of calibration, etc.); is the validity of the previous measuring results investigated? Are appropriate actions taken on the measuring device and any product affected? |
| When computer software is used in the monitoring and measurement of specified requirements; is the software validated? |
| Is the extent of software validation based on risk associated with the use of the software? |
| Are measurement, analysis and improvement processes planned and implemented to • demonstrate conformity of the product, • ensure conformity of the QMS, and • maintain the effectiveness of the QMS? |
| Are applicable methods determined, including statistical techniques, for the measurement, analysis and improvement processes? Are sampling plans based on valid statistical rationale? Are they documented? Are sample sizes based on risk associated with the measured characteristic? Are there procedures to ensure that sampling methods are adequate and that when changes occur the sampling plans are reviewed? |
| Are methods determined for obtaining and using information related to whether the company has met customer requirements? Is there a system for obtaining and analyzing customer feedback to provide early warning of quality problems? Is customer feedback used as input into the corrective and preventive action processes? |
| Is information gathered in the feedback process used in risk management? |
| Is there a procedure for receiving, recording, reviewing and evaluating complaints? Are all complaints, including oral complaints, documented? Are complaints evaluated to determine whether the complaint represents an event which is required to be reported to the regulatory authorities (to FDA under Part 803 or 804)? |
| Are complaints reviewed and evaluated to determine whether an investigation and/or corrective action are necessary? Are all complaints involving the possible nonconformity of a device investigated (unless a similar investigation was already performed)? When no investigation and/or corrective action are made, is there a record with a justification why investigation was not required, and with the name of the person who is responsible for this decision? |
| When a complaint represents an event that must be reported to regulatory authorities, is the complaint file so identified and does it include a determination of • whether the device failed to meet specifications, • whether the device was being used for treatment or diagnosis, and • the relationship, if any, of the device to the reported incident or adverse effect? |
| Do records of complaint investigations include • the name of the device and any device identifications and control numbers; • the date the complaint was received; • the name, address and phone number of the complainant; • the nature and details of the complaint; • the dates and results of the investigations; • any corrective action taken; and • any reply to the complainant? Are these records reasonably accessible to organization(s) responsible for manufacturing the device? Are these records reasonably accessible in the United States? |
| Are there documented procedures for providing notification to regulatory authorities regarding reportable complaints? When a complaint represents an event that must be reported to regulatory authorities, is the complaint file so identified and does it include a determination of • whether the device failed to meet specifications, • whether the device was being used for treatment or diagnosis, and • the relationship, if any, of the device to the reported incident or adverse effect? |
| Are internal audits planned and conducted to determine whether the quality management system conforms to requirements and whether it is effectively implemented and maintained? |
| Are audit criteria, scope, frequency and methods defined and documented? Is the audit process objective and impartial? |
| Are corrective actions taken to eliminate detected nonconformities and their causes? Are corrective actions followed up to verify the actions taken and to report the verification results? |
| Are quality system processes monitored and measured? When planned results are not achieved, are corrections and corrective actions taken to ensure conformity of the product? |
| Are all product acceptance activities (in-process and final inspections and tests) carried out in accordance with planned arrangements and documented procedures? Are in-process products controlled to prevent their use (further processing) before the required acceptance activities are completed? |
| Are there effective measures implemented to prevent release of product for distribution before • all activities required in the DMR are completed, • the associated data and documentation is reviewed, and • the release is dated and is authorized by a signature of a designated person(s)? |
| Are acceptance and release records maintained and include • identification of acceptance activities performed and, where appropriate, the methods and equipment used, • the results, and • dates and signatures of individual performing the acceptance activities? Are these records included in the DHR? |
| Are nonconforming products properly identified and controlled to prevent their unintended use or delivery? |
| Does evaluation of nonconformities include the determination of the need for an investigation and notification of the persons or external organizations responsible for the nonconformity? |
| Are records maintained of the nonconformities and any subsequent action taken? |
| Are nonconforming products evaluated to determine the nature and causes of the nonconformity and to disposition whether to • eliminate the nonconformity (rework), • authorize their use, release or acceptance (accept as-is by concession), or • preclude their original use or application (scrap or re-grade)? |
| When nonconforming product is accepted by concession, is there a record of • justification • review to ensure that applicable regulatory requirements are met, • customer approval (if applicable), • identity of person authorizing the concession? |
| Are actions taken to mitigate the effects of nonconformity when a nonconforming product has been shipped (or use has started)? |
| Is there a procedure for issue and implementation of advisory notices? Is this procedure capable of being implemented at any time? |
| If product needs to be reworked, are the rework processes documented and approved? Are reworked and repaired products re-verified to demonstrate their conformity? Is a determination made whether there are any adverse effects of rework upon the product? Is this determination documented? Is it included in the DHR? |
| Are appropriate data on the performance of the quality management system collected and analyzed, to include • customer feedback, • product conformity, • characteristics and trends of processes and products (including opportunities for preventive actions), • suppliers • service reports? |
| Are changes necessary to maintain the suitability and effectiveness of the quality system identified and implemented, through the use of • quality policy • quality objectives, • audit results, • analysis of data, • corrective and preventive actions, and • management reviews? |
| Are actions taken to eliminate causes of existing nonconformities to prevent recurrence? |
| Is there a documented procedure for • analyzing sources of quality and quality performance data to identify and reviewing nonconformities; • investigating the causes of nonconformities; • planning and implementing the actions needed to correct and prevent recurrence of nonconforming product or other quality problems; • reviewing the effectiveness of corrective actions; • verifying that preventive action does not adversely affect the ability to meet regulatory requirements, or the safety and performance of the medical device; • maintaining records of corrective actions and their results? Is there a process for verifying that corrective action does not adversely affect the ability to meet regulatory requirements, or the safety and performance of the medical device? |
| Are actions taken to eliminate causes of potential nonconformities to prevent their occurrence? |
| Is there a documented procedure for • determining potential nonconformities and their causes; • planning and implementing the actions needed to prevent potential nonconformities; • reviewing the effectiveness of preventive actions; • verifying that preventive action does not adversely affect the ability to meet regulatory requirements, or the safety and performance of the medical device; • maintaining records of preventive actions and their results? |
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Executive in Residence at Washington University