case study

Technical File Remediation

A Notified Body warned a large medical device company that their ISO certification would be withdrawn. RCA provided leadership and withdrawal of ISO certification was avoided.

About RCA
Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the pharmaceutical, biologic, sterile compounding, biotechnology, and medical device industries for resolution of compliance and regulatory challenges.

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Technical File Remediation

RCA provided leadership and resourced the remediation, so withdrawal of ISO certification was avoided.

Background

A Notified Body warned a large medical device company that their ISO certification would be withdrawn unless serious inadequacies in the technical files supporting their products were addressed in a timely manner. 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.

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.

Approach

RCA led and resourced remediation teams 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.

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, to coordinate the required 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.

References

  1. International Standards Organization, ISO Standard 13485: Medical devices—Quality management systems—Requirements for regulatory purposes. Second Edition, July 15, 2003.
  2. 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.
  3. International Standards Organization, ISO Standard 14971: Medical devices—Application of risk management to medical devices. 2007.
  4. International Standards Organization, ISO Standard 11607-2: Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes. 2006.

RCA provided leadership and resourced the remediation, so withdrawal of ISO certification was avoided.

Background

A Notified Body warned a large medical device company that their ISO certification would be withdrawn unless serious inadequacies in the technical files supporting their products were addressed in a timely manner. 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.

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.

Approach

RCA led and resourced remediation teams 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.

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, to coordinate the required 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.

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