FDA Medical Device GMP Consulting
Expert FDA Consultants for Medical Device QMSR & GMP Compliance
Are you a medical device manufacturer seeking FDA compliance and quality assurance expertise? Look no further. At Liberty Management Group Ltd. (LMG), we specialize in providing top-tier consulting services tailored to the unique needs of the medical device industry. Our mission is to help you navigate the complex regulatory landscape, ensure your products meet current Good Manufacturing Practice (CGMP) requirements, and bring safe and effective medical devices to market.
Important Update: The QSR Is Now the QMSR
On February 2, 2026, the FDA’s medical device quality requirements changed significantly. The longstanding Quality System Regulation (QSR) was replaced by the Quality Management System Regulation (QMSR). Under the revised 21 CFR Part 820, the FDA now incorporates ISO 13485:2016 by reference, meaning that compliance with ISO 13485:2016 — together with certain FDA-specific requirements — is now the foundation of the CGMP requirements for finished medical devices distributed in the United States.
A few key points for manufacturers:
- 21 CFR Part 820 remains the governing regulation and citation; its content now points to ISO 13485:2016.
- The QMSR is not identical to ISO 13485:2016 — the FDA layers additional requirements on top (for example, on labeling, unique device identification, and recordkeeping).
- ISO 13485:2016 certification does not exempt your facility from FDA inspection. As of February 2, 2026, the FDA also replaced its legacy QSIT inspection approach with an updated inspection process.
LMG helps manufacturers understand exactly what changed, what carried over, and what new steps are required to remain compliant under the QMSR.
Why Choose LMG?
As experienced FDA consultants, we understand the critical role that quality system compliance plays in the medical device industry. Our team guides you through the intricacies of the QMSR and ISO 13485:2016, offering a comprehensive range of services:
QSR-to-QMSR Transition Support: We help you map your existing quality system to the new QMSR and ISO 13485:2016 framework, identify gaps, and update procedures, terminology, and records accordingly.
Regulatory Strategy and Planning: We work closely with you to develop a customized regulatory strategy that aligns with your business goals — evaluating your product’s classification, preparing regulatory submissions, and providing strategic advice to streamline your path to market.
Quality Management System Implementation: Our consultants help you establish and maintain a robust Quality Management System (QMS) compliant with 21 CFR Part 820 as amended by the QMSR and ISO 13485:2016. We help you design and implement SOPs, conduct risk-based assessments, and keep your quality system audit-ready at all times.
QMSR & ISO 13485 Training and Workshops: Education is the cornerstone of compliance. We offer customized training and workshops that bring your team up to speed on the QMSR and ISO 13485:2016 requirements.
Audits and Inspection Readiness: Our consultants conduct thorough mock audits and gap assessments to identify areas for improvement and ensure your facility is prepared for FDA inspections and notified-body audits under the new framework.
Compliance Remediation: If you are facing compliance issues or an FDA Form 483 or warning letter, we help you develop and implement effective corrective and preventive actions (CAPA) to resolve concerns swiftly and sustainably.
Post-Market Surveillance: Ensuring ongoing safety and effectiveness is crucial. We assist in developing robust post-market surveillance plans and monitoring adverse events so you can respond proactively to potential issues.
Regulatory Submissions: From premarket submissions (510(k), PMA) to post-market programs (MDSAP, MDR), we have the expertise to prepare and submit required documentation accurately and efficiently.
Our Commitment to Excellence
At LMG, we are committed to providing unparalleled FDA consulting services. Our consultants stay current with the latest FDA regulations — including the QMSR transition — industry trends, and best practices, so you receive the most relevant and practical guidance. We take pride in our track record of helping medical device manufacturers achieve and maintain compliance.
Get Started Today
Ready to take your medical device quality system to the next level under the new QMSR? Contact us today to schedule a consultation. Let LMG be your trusted partner on the journey to FDA compliance and medical device excellence.
GMP Consulting Services — 21 CFR Part 820 & QMSR
LMG helps medical device manufacturers build and maintain QMS compliant with FDA requirements.
Document Controls
Establish and maintain document and record control procedures under 21 CFR Part 820, now aligned with ISO 13485:2016 Clause 4.2. We help you control approval, distribution, versioning, and retention so your documentation stays audit-ready.
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Design Controls
Implement design and development controls under 21 CFR Part 820, now governed by ISO 13485:2016 Clause 7.3. We support planning, design inputs and outputs, verification, validation, and design transfer throughout your product lifecycle.
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CAPA System
Build a corrective and preventive action (CAPA) system under 21 CFR Part 820, aligned with ISO 13485:2016 Clause 8.5. We help you investigate root causes, implement corrective actions, and verify effectiveness to prevent recurrence of quality issues.
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Purchasing Controls
Develop supplier qualification and purchasing controls under 21 CFR Part 820, now based on ISO 13485:2016 Clause 7.4. We help you evaluate, approve, and monitor suppliers using a risk-based approach to safeguard product quality.
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Audit Preparation
Prepare for FDA inspections and notified-body audits with a thorough pre-inspection gap assessment. We review your quality system against QMSR & ISO 13485:2016 requirements and provide actionable steps to close any gaps.
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483 Response
Respond effectively to FDA Form 483 observations and warning letters with a clear, defensible plan. We help you draft corrective actions, document your remediation, and demonstrate sustainable compliance to the FDA.
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Frequently Asked Questions
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Contact LMG to discuss your 21 CFR 820 GMP and QMSR compliance requirements.
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