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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A Notified Body warned a large medical device company that their ISO certification would be withdrawn unless serious inadequacies in the technical files were addressed.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® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:
We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies. As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.
- Founded in 2000
- Headquartered in Wisconsin (USA)
- Regional offices in Florida, Colorado and Europe
- Expertise backed by over 500 industry subject matter experts
- Acquired by Sotera Health in 2021
To begin the RCA® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.
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.
