Client Background
This case study focuses on a U.S.-based medical device manufacturer specializing in endotracheal tubes. The company operates in a Class 10,000 (Federal Standard 209E Class 7 under ISO 14644-1) clean-room environment and aimed to establish compliance with FDA’s 21 CFR 820 and obtain 510(k) clearance for their endotracheal products.
Challenge Faced
The primary challenge was to build a compliant Quality Management System (QMS) from scratch to meet the stringent requirements of 21 CFR 820, and to prepare for a 510(k) premarket notification submission for their endotracheal tubes.
Medfins International’s Strategy and Implementation:
Medfins International provided end-to-end support and expertise in regulatory compliance, QMS development, and 510(k) submission.
1. Initial Documentation Establishment:
– Medfins initiated the project by developing foundational QMS documentation aligning with 21 CFR 820, which included creating and standardizing SOPs, work instructions, and quality policies.
2. Comprehensive Audit and Gap Analysis
– Conducted an in-depth initial audit to identify compliance gaps compared to 21 CFR 820 requirements, laying the groundwork for targeted improvements.
3. Document Review and Enhancement
– Enhanced existing documentation to ensure full compliance with regulatory standards, focusing on critical areas such as design control, risk management, and supplier qualification.
4. Staff Training Programs:
– Implemented extensive training programs to elevate staff understanding of 21 CFR 820, cleanroom operations, and quality management principles, ensuring a culture of quality and regulatory adherence.
5. Internal Audit and Compliance Assurance:
– Provided ongoing support during internal audits to assess the effectiveness of the QMS and identify opportunities for continuous improvement.
6. 510(k) Submission Preparation:
– Assisted in the preparation and submission of the 510(k) notification, ensuring all necessary documentation and product data were accurately compiled and presented in accordance with FDA guidelines.
Outcome and Current Status:
– The company successfully established a comprehensive and compliant QMS tailored to 21 CFR 820 regulations.
– The 510(k) premarket notification for the endotracheal tubes was submitted to the FDA, and the company is currently awaiting the review summary and decision.
– The device registration and establishment registration processes were completed successfully, marking key milestones in the company’s journey towards market readiness.
Conclusion:
This case study showcases Medfins International’s capability in guiding medical device manufacturers through the complexities of regulatory compliance and FDA submissions. The successful establishment of a 21 CFR 820 compliant QMS and the progression of the 510(k) submission process reflect Medfins International’s commitment to ensuring its clients not only meet regulatory requirements but are also well-positioned for market success. As the endotracheal tube manufacturer awaits the FDA’s decision, their preparedness and compliance with regulatory standards stand as a testament to the effective partnership and support provided by Medfins International.