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June 05, 2020

How Do You Break Down the IVDR Proverbial Elephant Before it Breaks You?

We are excited to welcome our guest blogger, friend, and expert in the diagnostics industry Terrie Dosenberry. Terrie is the Director of Program Management for Quality Assurance and Regulatory Affairs at Hologic’s Diagnostic Solutions Division based in San Diego, CA. Terrie is currently leading a global cross functional team of technical experts toward implementation of the IVDR.  
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June 05, 2020

FAQ Friday: Answers to your questions about Summary of Safety and Performance for IVDR devices

We are very excited about the many FAQ Friday questions we have received in the past months. Hopefully, you appreciate our expert vlogs and the answers were helpful. 🔎 In this weeks vlog, Sue Spencer answers questions about the SSP for IVDR devices.
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June 04, 2020

Usability of Unknown Provenance (UOUP)

Medical devices have been required to integrate usability engineering principles and user interface design characteristics into their safety design and development process within the last 20 years since medical device risk management introduced the concept of user error in the 2000 version of IEC 14971 (annex A).

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May 29, 2020

FAQ Friday: Answers to your questions about responsibilities of Economic Operators

We know there are a lot of questions regarding new regulations. Therefore, we are excited to introduce our new service: FAQ Friday. This week Stefan Menzl answers questions about responsibilities of Economic Operators.
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May 29, 2020

On demand Webinar: Is Your Documentation Ready for a Successful Clinical Evaluation? 

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