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.

Medical Device, Risk management

ISO 14971 Let’s Go! The Ultimate Guide to Risk Management in Medical Devices

Risk Management is defined as the “systematic application of management policies, procedures and practices to the tasks of analyzing evaluating controlling, and monitoring risk” Basically, risk management means the right people doing the right activities at the right time to prevent harm.

Design & Development, Medical Device

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