Streamlined Quality Management for SaMD Companies

Navigating regulatory requirements for Software as a Medical Device (SaMD) can be challenging. Our QMS Implementation and Support services provide a cost-effective, scalable solution tailored for SaMD companies targeting the U.S. market. Whether you are launching your first medical device or scaling operations, we ensure your quality management system (QMS) meets FDA requirements and, if desired, is ready for ISO 13485/MDSAP certification.

Who We Help

Our QMS services are designed for:

• SaMD companies looking for a streamlined, regulatory-compliant QMS.
• Startups and growing firms that need a cost-effective, minimalist approach to quality management.
• Companies seeking FDA compliance and potential ISO/MDSAP certification.
• Clients new to QMS implementation, needing full setup and regulatory alignment.
• Companies with an existing QMS requiring targeted support such as FDA gap analyses, DHF coaching, internal audits, post-market surveillance, and compliance updates.

Our QMS Implementation and Support Services

Full-Scope QMS Implementation

We provide end-to-end QMS setup and support, ensuring compliance by the time of your 510(k) clearance. Key deliverables include:

• Medtech OS or other QMS platform
• FDA Facility Registration & Device Listing
• UDI support and GUDID registration
• Initial training, supplier qualifications, and Design History File records
• Internal audit and management review within the first year
• Inspection and audit readiness support for FDA and/or ISO/MDSAP audits
• Post-market compliance services for continued regulatory alignment

Our Approach to QMS Roll-Out

We follow a structured, efficient methodology to implement your QMS seamlessly:

1. Scoping & Planning

• Define scope based on market, applicable standards (21 CFR 820, 803, 806, etc.), and regulatory goals
• Select QMS platform based on company goals and budgets (Medtech OS, Greenlight Guru, Qualio, etc.)
• Develop a tailored implementation plan with clear timelines

2. QMS Implementation & Rollout

• Prioritize key procedures: Design & Development, Risk Management, Cybersecurity, Document Control, Training, and Supplier Qualifications
• Develop and implement SOPs, Work Instructions, and records
• Conduct training

3. Post-Market Compliance & Maintenance

• Facilitate FDA establishment registration, device listing, UDI setup, and GUDID registration
• Support management reviews, internal audits, and ongoing compliance
• Provide inspection readiness support for FDA or ISO audits

On-Demand QMS Consulting

For companies with an existing QMS, we provide as-needed support, including:

• FDA compliance assessments and gap analyses
• Routine Quality Assurance support, such as internal audits, management reviews, design changes, supplier qualifications, CAPAs, complaint handling, reportable events, etc.
• Post-Market Surveillance
• Response preparation for FDA 483s, warning letters, IHCTOA letters, etc.

Pricing

• $60,000 fixed price for full QMS implementation using Medtech OS (excludes certification):
  • $10,000 for project kick-off and planning.
  • $25,000 for pre-market QMS implementation.
  • $25,000 for post-market QMS implementation.
  • $2,500/quarter Medtech OS fee once the implementation is complete.
• Optional monthly retainer for ongoing QMS support (cost varies based on company needs).
• Additional costs to be estimated if using third-party QMS tools like Greenlight Guru or Qualio and for companies seeking ISO/MDSAP certification support.

Why Choose Us?

• SaMD-Focused Expertise – Our QMS is designed specifically for software-based medical devices.
• Efficient, Cost-Effective Solutions – We streamline compliance without unnecessary complexity.
• Integrated Regulatory & QMS Services – Seamlessly align your QMS with 510(k) or De Novo submissions.
• Long-Term Compliance Support – Ongoing maintenance ensures continuous regulatory readiness.