Objective:

To provide startups with a structured, ongoing compliance support system that ensures adherence to FDA, MDR, ISO, and other regulatory requirements throughout the product lifecycle—from development to post-market surveillance.

Service Components:

  1. Regulatory Roadmap & Readiness Assessment
    • Conduct an initial compliance gap analysis.
    • Develop a step-by-step regulatory strategy based on your device classification and target markets.
    • Identify key submission requirements (FDA 510(k), PMA, De Novo, MDR, etc.).
  2. Risk-Based Verification & Validation (V&V) Strategy
    • Define a risk-based testing approach to optimize efficiency.
    • Ensure verification and validation activities align with regulatory expectations.
    • Support test execution and documentation best practices.
  3. Quality System Setup & Maintenance
    • Implement a right-sized ISO 13485-compliant Quality Management System (QMS) suitable for startups.
    • Establish essential procedures for design controls, risk management, supplier quality, and complaint handling.
    • Train your team on quality best practices and documentation.
  4. Regulatory Submissions Support
    • Assist with FDA, EU MDR, and international regulatory submissions.
    • Review and refine technical documentation and risk files.
    • Provide guidance on interactions with regulatory bodies.
  5. Post-Market Compliance & Surveillance
    • Establish and maintain post-market surveillance (PMS) and complaint handling processes.
    • Support clinical evaluation reports (CERs) and post-market clinical follow-up (PMCF).
    • Ensure ongoing compliance with changing regulations.
  6. On-Demand Compliance Advisory
    • Provide a subscription-based or retainer service for ongoing regulatory and quality support.
    • Offer quarterly compliance check-ins and audits.
    • Be available for urgent compliance issues or regulatory inquiries.

Why Choose our Compliance Guard Service?

✅ Tailored for Startups: Right-sized compliance solutions that scale with your growth.
✅ Risk-Based Approach: Focus on practical, efficient compliance strategies.
✅ Expert Guidance: Leverage over 30 years of hands-on medical device experience.
✅ Regulatory Confidence: Stay audit-ready and avoid costly compliance pitfalls.

Get Started Today!

Ensure your medical device startup stays compliant and market-ready with expert support. Contact MAK & Associates, LLC today to discuss how Compliance Guard can protect your innovation and accelerate your success!