Background

A Notified Body warned a large medical device company that their ISO certification would be withdrawn unless serious inadequacies in the design history file (DHF) were addressed. ISO certification withdrawal would mean that the CE Mark could no longer be applied to product labeling, and the products could no longer be sold in countries where the CE Mark is required. An internal gap analysis suggested a technical file remediation strategy was missing. 

Challenge

Regulatory Compliance Associates^® was contracted to provide program oversight as well as teams of resources, spread across several design centers and manufacturing sites. The objective was to coordinate the required design history file remediation activities. Due to the extent of remediation needed, a phased, risk-based implementation strategy was used to ensure efficient progress in accordance with budget limitations.

Approach

RCA led and resourced DHF remediation team in the following areas:

• 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

Design history files for each product family were updated as comprehensive testing and DHF documentation was completed. The Notified Body was satisfied with the program progress and the quality of remediation accomplished, and withdrawal of ISO certification was avoided.

 

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