We've gathered all the commonly asked questions about the ISO 14971 Standard together with expert answers.
Download the Free ISO 14971 e-Book for answers.
Here, we at deGRANDSON Training, a provider of Risk Management Courses, have assembled a comprehensive set of ISO 14971, Risk Management for Medical Devices, FAQS...
- What is ISO 14971?
- What is the purpose of ISO 14971?
- What are the Benefits of using ISO 14971?
- Is the use of ISO 14971 mandatory?
- Is ISO 14971 intended for Medical Device Manufacturers only?
- Do applicable regulatory requirements in ISO 13485 include ISO 14971 and other ISO Standards?
- Where does ISO/TR 24971 apply?
- Can we get certified to ISO 14971?
- What's new in the 2019 version of ISO 14971?
- Why isn't an FMEA enough?
- What does the lifecycle approach mean in practice?
- Do Internal Auditors need training in ISO 14971?
Click on the e-Book image to get your copy...
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