Background

A large medical device manufacturer received a critical warning from its Notified Body: unless significant deficiencies in its Medical Device Directive (MDD) technical files were corrected promptly, the company’s ISO certification would be withdrawn. Loss of certification would prevent the continued use of the CE Mark, effectively halting sales in all markets where CE Marking is required.

To address this urgent risk, Regulatory Compliance Associates® Inc. (RCA) was engaged to provide program oversight and deploy expert teams across multiple design centers and manufacturing sites. RCA was also tasked with supporting the transition from MDD to the EU Medical Device Regulation (MDR). Given the scope and complexity of the remediation effort, a phased, risk-based implementation strategy was developed to ensure steady progress within defined budget constraints.

Approach

RCA led and staffed cross-functional remediation teams to address gaps across a wide range of critical areas, including:

• Customer Requirements
• Risk Management – Use, Design, and Process
• Sterilization Validation
• Design Validation Testing
• Essential Requirements Checklist
• Product Specifications
• Design Verification Testing
• Shelf Life Testing – Product and Package
• Process Validation
• Remediation included gap analyses, development and execution of test protocols, risk analyses, and updating of documentation as required to support the technical files for each product family.

Result

As remediation activities were completed, updated technical documentation was submitted for each product family. The Notified Body acknowledged the quality and thoroughness of the remediation program and the steady progress made. As a result, ISO certification was maintained, CE Marking privileges were preserved, and the company avoided costly market disruptions.