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Technical File Remediation
Background
A Notified Body warned a large medical device company that their ISO certification would be withdrawn unless serious inadequacies in the technical files were addressed.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.
RCA provided leadership and resourced the remediation, so withdrawal of ISO certification was avoided.
Challenge
Regulatory Compliance Associates® Inc. 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 technical 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 technical file 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
Technical files for each product family were updated as comprehensive testing and 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.
About RCA
Regulatory Compliance Associates® Inc. is widely recognized within the life science industry and global regulatory agencies for its ability to help companies successfully resolve complex regulatory challenges, including remediation.
With a proven track record of success, we have significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters and Consent Decrees.
Our value goes beyond the initial response by helping companies successfully execute their action plans, develop an improved compliance culture tailored to the needs of their business, and ultimately move beyond the regulatory action to emerge as a stronger business.
We negotiate difficult demands of remediation with insight and the clear advantage of our unique expertise and experience that makes partnering with RCA® Inc. a competitive differentiator in the remediation space.
- Quality System
- Technical File and Design History File (DHF)
- Data Integrity
- Regulatory Action
- Manufacturing and Facility Validation
- Part 11 and Computerized System Validation
References
- International Standards Organization, ISO Standard 13485: Medical devices—Quality management systems—Requirements for regulatory purposes. Second Edition, July 15, 2003.
- International Standards Organization, ISO Standard 11137-1: Sterilization of Healthcare Products—Radiation—Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices. 2006.
- International Standards Organization, ISO Standard 14971: Medical devices—Application of risk management to medical devices. 2007.
- International Standards Organization, ISO Standard 11607-2: Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes. 2006.
