Medical Device, Risk management

Video | Risk Management in Medical Devices

What is Risk Management? Here is a beautiful presentation to help you understand what Risk Management in Medical Devices looks like in compliance with ISO 14971; the standard for the application of risk management to medical devices.

Design & Development, Medical Device

Video | FDA’s MAUDE database: A medical device expert’s insight

https://youtu.be/OS2unSk68KQ   The Manufacturer and User Facility Device Experience, or MAUDE, database is a tool that I use to help discover potential hazards when developing design input specifications for medical devices. It's very useful and I highly recommend this resource. Here is a simple guide I made to get your search started.       … Continue reading Video | FDA’s MAUDE database: A medical device expert’s insight