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Product Development

The Medical Device Practical Guide to PMCF Requirements under EU MDR

October 3, 2022
The European Medical Device Regulation (EU MDR) deadlines are closing in for re-certification and/or introduction of new products. Read More
Product Development

3 Tips For Incorporating Risk Management During Medical Device Product Development

September 30, 2022
Medical device product development and risk management are often treated as entirely separate processes. Sure, there is usually acknowledgement and understanding that these... Read More
Product Development

10 Tips for Selecting the Right EDC Software for Clinical Investigations

September 29, 2022
Using Electronic Data Capture (EDC) software can save you time and money in the data collection process for your medical device clinical investigation - but how do you... Read More
Product Development

7 Common 510(k) Mistakes and How to Avoid Them

September 28, 2022
The 510(k) is the workhorse of regulatory submissions to the FDA from the medical device industry in the United States. However, 510(k)s continue to be the source of... Read More
Product Development

Medical Device Classification Guide - How To Determine Your Device Class

September 28, 2022
What I am about to share with you is a guide to medical device regulatory classification. Read More
Establishing a QMS

Four Years, For You

September 27, 2022
Celebrating Four Years as the Leading QMS, as Selected by Users Read More
Product Development

Ultimate Guide to Supplier Management for Medical Device Companies

September 25, 2022
A medical device is only as good as its parts. Read More
Product Development

IEC 82304 vs IEC 62304: Software Standards for SaMD Explained

September 23, 2022
IEC 82304-1 is one of many standards that medical device companies should use while developing software as a medical device (SaMD). It covers the requirements for... Read More
Product Development

Compliant Adverse Event Reporting in Clinical Studies under the EU MDR

September 22, 2022
Under the EU MDR, both pre- and post-market clinical investigations shall follow the latest requirements for Good Clinical Practice (ISO 14155:2020). Recording and reporting... Read More

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