Expert Advice Community

Home / ISO 13485 & EU MDR / Risk Management

Guest

Risk Management

ISO 13485 & EU MDR
  Quote
Guest
Guest user Created:   Nov 08, 2023 Last commented:   Nov 08, 2023

Risk Management

ISO 13485 & EU MDR

Our company has no prior risk management documents on any devices to prepare the risk management packages. I was thinking if I can help engineers by having some samples of similar devices to ours? What is your thought on it?

0 0

Assign topic to the user

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.
Expert
Kristina Zvonar Brkić Nov 08, 2023

This is a good approach. The point is that these similar devices should have a similar intended purpose and be produced by similar technological processes. 

Quote
0 0

Comment as guest or Sign in

HTML tags are not allowed

Nov 08, 2023

Nov 08, 2023

Suggested Topics
Guest user Created:   Jun 07, 2023 ISO 13485 & EU MDR
Replies: 1
0 0

Risk Management Question
Guest user Created:   Apr 21, 2023 ISO 13485 & EU MDR
Replies: 1
0 0

Should we have risk management procedure including FMEA for all product lifecycle?
Guest Created:   Nov 22, 2022 ISO 13485 & EU MDR
Replies: 1
0 0

MDR/ISO 13485 risk management of "SYSTEM"

This website stores cookies on your computer. These cookies are used to collect information about how you interact with our website and allow us to remember you. We use this information in order to improve and customize your browsing experience and for analytics and metrics about our visitors both on this website and other media. To find out more about the cookies we use, see our Privacy Policy.

If you decline, your information won't be tracked when you visit this website. A single cookie will be used in your browser to remember your preference not to be tracked.