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.