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Definitive Guide to Change Management for Medical Devices - Featured Image

Definitive Guide to Change Management for Medical Devices

By Jon Speer on November 17, 2019
Implementing Changes to SaMD under New EU MDR - Featured Image

Implementing Changes to SaMD under New EU MDR

By Nick Tippmann on September 4, 2019
Classification, qualification, and other changes to Software as a Medical Device (SaMD) under the ne...
What Should Really Trigger a CAPA? - Featured Image

What Should Really Trigger a CAPA?

By Jon Speer on April 4, 2017
Over years of working with medical device companies, we’ve found that there is a particular area tha...
Understanding the New FDA Guidance on Changes to a 510(k) - Featured Image

Understanding the New FDA Guidance on Changes to a 510(k)

By Nick Tippmann on October 26, 2016
What happens you need to make a change to a device that’s been cleared via 510(k)?
5 Places Paper Might Be Hiding in Your Medical Device Company - Featured Image

5 Places Paper Might Be Hiding in Your Medical Device Company

By Jesseca Lyons on July 11, 2016
A few weeks ago you left a big pile of paperwork (also known as your Document Change Order (DCO/ECO)...
Dirty Devices and Reprocessing: Are New Design Change Rules On the Horizon? - Featured Image

Dirty Devices and Reprocessing: Are New Design Change Rules On the Horizon?

By Nick Tippmann on June 1, 2016
As medical device developers, it is our responsibilities to make sure that our products are safe and...

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