At the heart of medical device advancement, we excel in the design, development, validation, and ongoing support of Software as a Medical Device (SaMD). Our team of seasoned software engineers, combined with our robust regulatory frameworks, ensures a swift and seamless journey to market for your innovative solutions.
We are proud to partner with a diverse array of clients, from visionary startups to industry-leading Fortune 500 companies. Our portfolio includes:
We engage with our clients in several models, as is appropriate for their existing staff, funding, compliance, and strategic needs.
Innolitics manages the regulatory strategy and FDA submission (typically a 510(k) or De Novo) as well as the full software development and validation. This engagement model is appropriate for teams who don’t have FDA regulatory expertise and would like a full-service, end-to-end solution for a new SaMD product or accessory.
Innolitics handles the full software development and validation. This engagement model is appropriate for teams who have existing regulatory expertise and are looking for a full-service, end-to-end software development partner. We can provide the full Design History File (DHF) as well as all of the regulatory documents
Based on a client’s needs, we can design an approach that best aligns our regulatory, engineering, AI/ML, and cybersecurity capabilities with your business goals. We take into account your organizational structure and existing resources. Possible arrangements include:
Medical device software typically requires on-going maintenance due to
Furthermore, most Software as a Medical Device products (unlike Software in a Medical Device) tends to undergo new feature development well past the first version.
Once the first release is completed and validated, we can transfer the design, source code, and infrastructure to your team. We also provide on-going support, including installation, servicing, cybersecurity monitoring, and new feature development. We’ve also helped several startups build out their own engineering teams, assisting with hiring and ultimately phasing out our involvement with the software.
Our expertise spans across a broad range of SaMD applications. We specialize in creating solutions that are not only innovative but also compliant and secure, ensuring they meet the highest industry standards.
We have experience developing a variety of Class I and Class II Software as a Medical Device applications, including:
Our quality management system and development process adheres to the highest standards of quality and compliance, including IEC 62304 for medical device software, ISO 14971 for risk management, and AAMI TIR 57 for cybersecurity. Whether working within our quality management system or integrating with yours, we guarantee excellence and compliance at every stage.
Our design history documentation not only covers these standards, but is also up-to-date with the U.S. FDA’s latest software and cybersecurity guidance documents, including the following (when applicable):
We have deep expertise with these technologies:
We have some expertise with:
Our cybersecurity team can help you develop secure software that will keep patients safe and your and your customer’s data secure.
Since the FDA received additional statutory authority in March of 2023, it has become essential to understand FDA’s cybersecurity regulations and guidance to achieving pre-market clearance in the U.S.
Our Secure Product Development Framework (SPDF) incorporates:
Not only can we help write documentation for premarket submissions, but we can also help you navigate buyer’s IT concerns once you want to start selling your device. This includes providing copies of the MDS2 form and ensuring your device makes it easy for your customers to comply with the HIPAA’s security rule.
Our cybersecurity templates and the documentation we produce comply with the following FDA guidance:
Innolitics has deep expertise in image processing and algorithm development. Our algorithms have been deployed in several FDA cleared applications and we can build your algorithm as part of a new device or to augment an existing device. Our competencies include:
Our AI/ML and image-processing work is developed to comply with the following FDA guidance:
Read more about our AI/ML services here →
Many medical device startups wisely keep their functionality to a minimum for their first premarket submission. Once you're on the market, customers often ask you to integrate with EMR Systems, Lab Information Systems, and PACS.
We are DICOM experts. In fact, over 10,000 engineers and radiologists visit our DICOM Standard Browser each month, and it is often the top result in DICOM-related Google searches.
Our documentation complies with the following FDA guidance and standards:
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