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Product Development

5 Strategies to Limit Project Timeline and Cost for your Medical Device

May 30, 2022
Creating success in the medical device industry is about sustainable growth and repeatable processes. But all of that is really a longer way of saying “change management.” Read More
Product Development

Post-Market Clinical Follow-up Under EU MDR: Your Guide to PMCF Activities

April 28, 2022
The post-market clinical follow-up (PMCF) is one of several forms of post-market surveillance stipulated by the European Union Medical Device Regulation (EU MDR). Read More
Product Development

Ultimate Guide to Clinical Evaluation of a Medical Device in the EU

April 15, 2022
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Product Development

Navigating the Medical Device Single Audit Program (MDSAP)

April 13, 2022
Navigating the Medical Device Single Audit Program (MDSAP) may cover most of your regulatory requirements; however, it does not mean that your product will... Read More
Product Development

Everything You Need to Know About Root Cause Analysis

March 27, 2022
At some point, every medical device company will encounter an issue that requires an internal investigation. Read More
Product Development

4 Problems (and Solutions) for the Medical Device Supply Chain

March 18, 2022
If you had told me three years ago that supply chain economics and logistics would become a popular discussion topic, I would have raised an eyebrow or two.  Read More
Product Development

Creating a Periodic Safety Update Report (PSUR) that Complies with MDR & IVDR

February 6, 2022
The European Union Medical Device Regulation (EU MDR) and European Union In Vitro Diagnostic Regulation (EU IVDR) represent a complete overhaul of the EU regulations for... Read More
Establishing a QMS

What Should Really Trigger a CAPA?

January 30, 2022
Corrective and preventive action (CAPA) is often a thorn in the side of medical device manufacturers. Problems with CAPA top the list of reasons for 483s and warning letters... Read More
Product Development

Tips for Virtual Audits Your Medical Device Company Can Implement Today

December 7, 2021
Auditing medical device manufacturers is one of the most important aspects of ensuring quality standards. Read More

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