Challenge:
A long-standing client, a small company specializing in innovative minimally invasive endosurgical devices, needed to maintain their existing CE Mark while updating their QMS to comply with the new Medical Device Regulation (MDR). Facing limited resources to implement the new regulations and update their documentation for an MDR submission, they trusted AlvaMed’s proven track record and deep understanding of the regulatory landscape.
Approach: AlvaMed implemented a two-phase approach:
- Gap Analysis: AlvaMed assessed the existing QMS and technical documentation to identify any areas not aligned with the MDR. Next AlvaMed worked with the client to design an approach to fill those gaps.
- MDR Compliance Roadmap: Drawing from their complete library of MDR templates and extensive expertise in implementing QMS, AlvaMed collaborated with the client to develop a targeted and efficient plan to update the QMS and support technical documentation creation to complete the CE Mark submission.
Results: AlvaMed delivered the following:
- MDR-compliant QMS: Updated and optimized the client’s QMS to ensure compliance with the MDR requirements.
- Streamlined Documentation: Provided MDR-compliant templates and guidance for revising the technical documentation efficiently.
- Notified Body Audit Support: Prepared the client for and supported them during the notified body audits, resulting in:
- MDR Certification with Minor Nonconformances: The client successfully achieved MDR certification with only minor issues, demonstrating the effectiveness of AlvaMed’s approach.
Impact: This case study demonstrates the tangible impact AlvaMed can have on clients navigating complex regulatory changes. By providing expert guidance, efficient tools, and unwavering support, we help clients achieve their compliance goals and ultimately, improve patient outcomes.
Takeaways:
- Reduced burden and risk: Streamlined the MDR transition process, saving the client valuable time and resources.
- Enhanced compliance: Updated the QMS and technical documentation to meet the rigorous MDR requirements, minimizing the risk of non-compliance issues.
- Efficient documentation: Leveraged AlvaMed’s MDR templates and expertise to expedite documentation updates, reducing costs and delays.
- Confident audits: Prepared the client for and supported them during notified body audits.
- Market access secured: With the MDR requirements satisfied, the product previously approved through MDD is expected to remain on the market allowing for continued patient access to the critical technology.
