A strong Quality Management System is essential for any medical device manufacturer aiming for regulatory success. Whether you’re building your QMS from scratch or refining an existing one, Sobel’s medical device quality consulting services provide the structure, clarity, and expert guidance your company needs.
Let Sobel check whether your processes are compliant, efficient, and ready for regulatory scrutiny.
Regulatory expectations require strong procedures, clear documentation, and objective proof of implementation.
A structured, compliant QMS prevents nonconformities, reduces inspection risks, and strengthens product quality and safety.
Expert guidance accelerates alignment with FDA and ISO requirements, turning complex rules into clear, actionable processes.
With increasing expectations from FDA 21 CFR 820, ISO 13485, and MDSAP, your QMS must go beyond documentation—it must work in practice.
Our medical device quality consulting services follow a clear, collaborative method that adapts to your company’s scope, maturity, and regulatory objectives.
Depending on your company’s stage and regulatory goals, you can request an internal audit, a gap analysis, targeted consulting support, or complete QMS implementation guidance.
Best for companies needing an independent, structured evaluation of their Quality Management System. This remote audit verifies procedure completeness, conformity with the applicable standard, and real-world implementation.
Ideal when you need a technical assessment of your Risk Management Plan and Report. We analyze gaps, evaluate alignment with ISO 14971, and provide clear improvement recommendations. The service focuses on analysis.
Designed for companies with an ISO 13485-based QMS needing alignment with U.S. FDA requirements. We review your Quality Manual and procedures, perform a gap assessment, and provide guidance for one revision.
For companies without ISO 13485 implementation. We review your QMS documents and assess gaps against 21 CFR 820 and ISO 13485:2016, providing guidance for one revision.
The most comprehensive option—ideal for startups or manufacturers building their first quality system. Includes assessment of applicable requirements, guidance for drafting procedures and the Quality Manual, review and gap assessment of drafted documents, internal audit execution, and support in preparing for certification audits.
Perfect for teams needing continuous guidance on quality-related questions. Your inquiries are submitted through our project management platform, and experts provide written answers.
Whether remotely or on-site, we guide your team through assessments, documentation reviews, internal audits, and improvement strategies, ensuring practical, inspection-ready outcomes.
From focused assessments to full QMS construction, Sobel delivers the structure and expertise needed to create a compliant, functional, and inspection-ready Quality Management System. You can also receive support with:
Expert-led training programs that strengthen risk management and compliance.
Support for CEP and CER development, including strategic planning, literature reviews and more.
A compliant, well-structured QMS is essential for regulatory success and long-term market access. Through Sobel’s medical device quality consulting, your team receives the clarity, efficiency, and practical guidance needed to align with FDA, ISO, and MDSAP requirements—without adding unnecessary complexity.
Start building a stronger, more compliant QMS today.
1. What is the difference between FDA 21 CFR 820 and ISO 13485?
FDA 21 CFR 820 is the U.S. Quality System Regulation (QSR), legally required for medical devices marketed in the United States. ISO 13485 is an internationally recognized QMS standard. The two are similar, but not identical—FDA requires additional controls, documentation, and inspection readiness that go beyond ISO 13485.
2. Does ISO 13485 certification guarantee compliance with FDA 21 CFR 820?
No. While ISO 13485 provides a strong foundation, it does not replace compliance with 21 CFR 820. Manufacturers still need to align documentation, processes, and implementation with FDA expectations.
3. Do I need a QMS if my product is not yet on the market?
Yes. FDA expects manufacturers to have a functioning, documented, and implemented QMS before submitting most applications or producing devices for distribution.
5. Is a remote internal audit acceptable for FDA compliance purposes?
Yes. FDA does not require internal audits to be on-site. Remote audits are acceptable as long as the review is thorough, documented, and evaluates both procedures and implementation.
6. How often should a medical device company perform internal audits?
At least once per year, or more frequently depending on device risk, recent changes, or preparation for an upcoming FDA inspection or certification audit.
7. Do I need separate procedures for FDA, ISO 13485, and MDSAP?
Not necessarily. A single, well-structured QMS can meet all three frameworks if it is designed properly. The key is ensuring your documentation reflects all applicable regulatory requirements.
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