Quality Management Support
If you’re preparing a medical device for the U.S. market, your Quality Management System (QMS) needs to be fully compliant with FDA 21 CFR 820. And whether you’re starting from scratch or refining an existing system, aligning with U.S. regulatory expectations can be complex.
This is why we specialize in helping manufacturers structure, optimize, and document their QMS for successful regulatory compliance.
With a focus on clarity, strategy, and results, we help you to make sure that your QMS works not only on paper—but in practice.
How We Support Your Quality Management System
What is a Quality Management System?
A QMS is a structured set of policies, procedures, and processes used to ensure consistent quality, regulatory compliance, and continuous improvement in medical device development and manufacturing. For the U.S. market, your QMS must comply with 21 CFR Part 820, the FDA’s Quality System Regulation.
Here’s how we support your journey to a compliant and effective system, FDA 21 CFR 820 Compliance made practical and effective:
Conduct internal audits based on FDA 21 CFR 820, including planning, procedure verification, and implementation checks
Compile detailed audit reports with findings, non-conformities, and corrective action guidance
Review and assess Quality Manual and procedures for completeness and compliance
Perform gap assessments and suggest precise revisions (one revision included)
Draft or refine QMS procedures tailored to your company’s structure and scope
Provide support in preparing for certification audits or FDA inspections
Offer guidance on resolving non-conformities identified during internal or external audits
Help integrate ISO 9001 Quality Management System principles when relevant, strengthening quality assurance and operational control
Why do you need this service?
FDA inspections require documentation and implementation proof. We help you build both—with zero guesswork.
No generic templates or bloated systems. We deliver focused solutions, so you invest only in what’s necessary to comply.
Whether you’re responding to FDA questions or prepping for a certification audit, we translate technical requirements into actionable steps.
Meeting FDA requirements isn’t just a checkbox—it’s a strategic necessity for safe and sustainable U.S. market access. With Sobel by your side, you gain expert guidance, faster compliance, and the confidence to face FDA requirements without unnecessary stress.
Looking for Quality Management Assistance?
With Sobel, you’re not alone in the maze of FDA regulations. We bring structure, expertise, and real results to your Quality Management System, so you can move forward with assurance.
Let’s talk. We make compliance practical—so you can focus on innovation and market growth.
