What To Know
- Developed by regulatory experts, the checklist is aimed at medical device companies who want to place a device in the EU market and need to comply with MDR guidelines.
- A technical file is a compilation of all the technical information about a medical device.
Kolabtree (an expert network) has announced the release of a new free resource for medical device manufacturers: The essential technical file checklist. Developed by regulatory experts, the checklist is aimed at medical device companies who want to place a device in the EU market and need to comply with MDR guidelines. It’s available to download for free here.
What is a technical file?
A technical file is a compilation of all the technical information about a medical device. This includes everything from the design of the product to how it’s manufactured and everything in between. It’s important to have a technical file because it provides essential information to regulators and helps ensure that medical devices are safe and effective. The technical file contains all the necessary documentation to support the regulatory submission, including test data, results, and analysis. It’s also used during post-market surveillance to help assess any safety issues that may arise with the device.
A technical file is a vital part of the EU MDR compliance process. In order to meet the requirements of the new regulation, medical device manufacturers must provide extensive technical documentation. This includes design and manufacturing files, technical specifications, user manuals, clinical evaluation reports, and more. Failure to submit a technical file can result in regulatory penalties, so it’s essential to make sure that your technical file is complete and accurate.
In order to make it easier for medical device manufacturers to comply with the EU MDR, Kolabtree has released a one-page technical file checklist. The checklist covers all of the essential components of a technical file, and helps you make sure that your documentation is complete and accurate. Kolabtree’s global network of medical device consultants offer services like medical writing, FDA/MDR compliance, data analysis, and more.
Download the Technical File checklist for free here.