What is new in ISO 14971:2019
in tAs you may know, in December 2019, the new updated version of the ISO 14971 was released. What does this update mean to you? Use this free checklist if you need help going over your own procedures and documents for the update. This video is an extract from the...FMEA vs ISO 14971
Many medical device manufacturers are working with FMEA. The concern is, does FMEA meet the regulatory requirements as to mark? Is FMEA the same as risk analysis? Or even risk management according to ISO 14971? This video is an extract from the online course Risk...
The Perfect Project Process for Medical Device Product Development
Having the perfect project process can be key in developing products in as short time as possible and as low cost as possible. It can allow you to exercise control over projects, especially in multi – project environment. A well-recognized project process will...
Risk management for medical device and ISO 14971 infographic
The whole medical device ISO 14971 risk management process in one picture The ISO 14971 standard is about 90 pages long. What if you could view the whole medical device ISO 14971 risk management process in one picture?! The infographic gives you the overview of risk...
How to Have Successful Risk Management Workshops
Getting started on risk management is sometimes the hardest part. A series of well-thought-out risk management workshops can give you a flying start in your work and allow you to avoid problems at a later stage. And the cost of changes increases the further you have...
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