Technical file creation
Budget: £250 – £750 GBP
Technical file to be created for a range of sizes for a single medical device.
At a minimum, the technical file should have:
A device description and specification section. This should also have your unique device identification (UDI) number.
Labeling and instructions for use. (Note: You will need a translation for the local language of the EU country you plan to enter).
Detailed information on design and manufacturing. (It is recommended that you make use of flow charts to clearly show processes and relationships). You need to show the manufacturing process, suppliers, and materials used.
Detailed risk management information in compliance with ISO 14971.
General Safety and Performance Requirements (GSPR), formerly known as essential requirements. It identifies all the things you must do for your device type. From a design control perspective, the contents of your traceability matrix will assist you with addressing the criteria of GSPR.
Verification and validation information. In terms of verification and validation, the European Commission places a heavy emphasis on clinical data - not just during design and development, but post-market, too. CERs (Clinical Evaluation Reports) should provide a comprehensive overview of the device’s design and composition, as well its intended applications and any relevant literature reviews.
Post-market surveillance (PMS) information, including PMS plan, post-market clinical follow-up (PMCF) plan, and periodic safety update report (PSUR).
At a minimum, the technical file should have:
A device description and specification section. This should also have your unique device identification (UDI) number.
Labeling and instructions for use. (Note: You will need a translation for the local language of the EU country you plan to enter).
Detailed information on design and manufacturing. (It is recommended that you make use of flow charts to clearly show processes and relationships). You need to show the manufacturing process, suppliers, and materials used.
Detailed risk management information in compliance with ISO 14971.
General Safety and Performance Requirements (GSPR), formerly known as essential requirements. It identifies all the things you must do for your device type. From a design control perspective, the contents of your traceability matrix will assist you with addressing the criteria of GSPR.
Verification and validation information. In terms of verification and validation, the European Commission places a heavy emphasis on clinical data - not just during design and development, but post-market, too. CERs (Clinical Evaluation Reports) should provide a comprehensive overview of the device’s design and composition, as well its intended applications and any relevant literature reviews.
Post-market surveillance (PMS) information, including PMS plan, post-market clinical follow-up (PMCF) plan, and periodic safety update report (PSUR).