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

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

Design & Development, Medical Device

How to turn User Needs into Design Specifications (with tables)

Creating your design input specification (DIS) should be the first stage of any product design process. It is a vital tool your Design Team will use as the framework for the design and development of your medical device, and to also comply with regulatory requirements. Wait! Just what is DIS? In the simplest terms, your… Continue reading How to turn User Needs into Design Specifications (with tables)

Design & Development, Innovation

KICKSTART YOUR DIS: 6 Approaches to Generate Design Inputs

A design input specification (DIS) plays a critical role in any product design process. The product DIS contains all the characteristics of a device that are used as a basis for product design. The level of detail that your design inputs cover can be the deciding factor that makes or breaks a smooth run to… Continue reading KICKSTART YOUR DIS: 6 Approaches to Generate Design Inputs