This is a change control standard operating procedure template. We designed it for medical device companies that want to fast track documenting their change control procedure. It is compatible with ISO 13485, the EU Medical Device Regulations 2017/745 and/or the FDA 21 CFR 820.
This is a verification results template for change control. We designed it for medical device companies that want to document action plans using their own change control procedures. It is compatible with ISO 13485, the EU Medical Device Regulations 2017/745 and/or the FDA 21 CFR 820.
This is an action plan template. We designed it for medical device companies that want to document action plans using their own change control procedures. It is compatible with ISO 13485, the EU Medical Device Regulations 2017/745 and/or the FDA 21 CFR 820.
Cybersecurity is a growing concern to patients and manufacturers of medical devices. If you are medical device manufacturer with cybersecurity concerns and want to make your medical device more secure, you should consider cybersecurity as part of your risk management.
If you don’t already have an approach that works for you, consider using the ‘RUBRIC FOR APPLYING CVSS [Common Vulnerability Scoring System] TO MEDICAL DEVICES’ published by the MITRE Corporation.
Having trouble estimating risks in your risk management (according to ISO 14971)? Check out a few tips we have put together that may make things easier for you.
Here are 5 great tips on how to label the workplace to avoid quality issues and errors.
