Managing the US regulatory demands can be a real challenge, but with our expertise in the 21 CFR Part 820, you can implement a rugged quality management system and confidently enter the US market.
At Russell Regulatory Consultants, we help medical device manufacturers align their operations with the FDA Quality System Regulation (QSR), ensuring your products meet all compliance requirements and achieve sustainable market access.
We provide end-to-end support to ensure your quality system complies with FDA expectations and is audit-ready. Our services include the following.
Identify gaps in your current system versus the 21 CFR 820 quality system regulation and receive a roadmap to compliance.
From policies to procedures, we guide you through designing and deploying a compliant quality management system.
Ensure your design history files (DHF), device master records (DMR), and other technical documentation meet FDA quality system regulation requirements.
Equip your team with the skills and knowledge to maintain QSR compliance, including internal audits and ongoing regulatory updates.
Prepare for FDA inspections with thorough internal audits and simulated inspections to reduce risks and ensure readiness.
Support for CAPA, complaint handling, and vigilance reporting under 21 CFR Part 820, ensuring continued adherence to QSR standards.
Compliance with the FDA quality system regulation isn’t optional. It’s essential for legal market entry in the US. Failure to comply can lead to warning letters, product recalls, and reputational damage. A well-implemented QMS improves product safety, streamlines operations, and supports efficient audits.
We combine technical expertise, regulatory insight, and hands-on experience to ensure your QMS meets the FDA’s stringent requirements.
Proven experience implementing 21 CFR Part 820 systems.
Tailored guidance for your specific devices and company processes.
Audit-ready documentation and procedures.
Ongoing training and competency programs.
Comprehensive gap analysis and remediation plans.
Continuous support for post-market compliance
Medical device manufacturers, IVD developers, and quality teams aiming to meet FDA quality system regulation requirements and confidently access the US market.
Take the first step toward full FDA QSR compliance and secure your US market access.
Implementing and maintaining a QMS that meets FDA requirements can be challenging. Here are answers to some common questions about 21 CFR Part 820 compliance:
The 21 CFR 820 quality system regulation (QSR) is the FDA framework that outlines requirements for medical device manufacturers to ensure their products are safe, effective, and compliant.
Any company manufacturing, reprocessing, or distributing medical devices in the US must implement a QMS that aligns with 21 CFR part 820.
Core elements include design controls, document controls, corrective and preventive actions (CAPA), complaint handling, and management reviews. These ensure robust regulatory risk management services.
We provide tailored support, including gap analysis, QMS implementation, documentation, training, internal audits, and ongoing regulatory guidance to meet FDA requirements.
ISO 13485 provides an international framework for QMS, while 21 CFR 820 is specific to the US. A QMS built to ISO 13485 can be adapted for FDA compliance with quality system regulations.
The timeline depends on your current system, product complexity, and internal resources. Our experts create a practical roadmap to efficiently achieve full compliance.
We would love to hear from you and discuss how our regulatory affairs specialists can support your regulatory compliance needs.