This Medical Device File procedure defines the requirements for medical device files to comply with ISO 13485:2016, Clause 4.2.3.
Medical Device File Procedure
This procedure is based upon the requirement for CE Marking technical files and the GHTF Guidance for Summary Technical Documents (STEDs). The procedure meets the requirements for Medical Device Files (MDFs) in ISO 13485:2016, Clause 4.2.3. This procedure should be used for compliance with the new FDA QMSR, Health Canada’s SOR 98/282, and TGA regulations. The following is a list of what is included with this procedure/webinar bundle:
- SYS-053 Medical Device File Procedure
- FRM-xxx Essential Requirements Checklist (ERC)
- FRM-040 Technical File Index/Device Master Record Index Template
- Login information for the live webinar on Monday, March 4, 2024
- Access to the record of the webinar if purchased after March 4, 2024
- Native slide deck for the training webinar
- Copy of the GHTF Guidance for Summary Technical Documents
The Medical Device File procedure listed above is compliant with ISO 13485:2016, Clause 4.2.3. If you need the previous versions of our procedure and forms, please let us know.
Anyone who purchased an older version of this procedure from us is entitled to an updated version at no additional cost.
Other Training Resources
If your firm is preparing for compliance with ISO 13485:2016, you might also be interested in the following information provided on this website:
- A webinar outlining how to create your own Quality Plan for compliance with the new FDA QMSR
- A webinar teaching internal auditors and consultants how to perform a thorough audit of technical files against the requirements of the new EU regulations.
Please note: This product will be delivered to the email address provided in the shopping cart transaction. After the transaction is verified, please check your email for the download. To view all available procedures click here.