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Documentation Priority for Early Stage Medtechs — Part 1: User Specification - Featured Image

Documentation Priority for Early Stage Medtechs — Part 1: User Specification

By Tommy Cooper on April 19, 2020
A common dilemma for early stage medical device companies is their lack of expertise in medical devi...
Only 6% of Device Makers Are Ready for EU MDR — Are You? Here are 3 Ways to Transition Now - Featured Image

Only 6% of Device Makers Are Ready for EU MDR — Are You? Here are 3 Ways to Transition Now

By Jon Speer on March 22, 2020
With the deadline for compliance with the EU MDR just around the corner, big changes are being made ...
How to Choose the Right FDA Regulatory Pathway for your Device - Featured Image

How to Choose the Right FDA Regulatory Pathway for your Device

By Nick Tippmann on February 26, 2020
Most medical device professionals and companies are familiar with Premarket Approval (PMA) and 510(k...
When Design Inputs Go Wrong + Design Your Label Like You Design Your Device - Featured Image

When Design Inputs Go Wrong + Design Your Label Like You Design Your Device

By Nick Tippmann on May 17, 2017
Today’s guest is Mike Drues, the president of Vascular Sciences and a world-renowned expert on all t...
3 Common Misconceptions About Medical Device Labeling - Featured Image

3 Common Misconceptions About Medical Device Labeling

By Jesseca Lyons on June 29, 2016
When you first start designing and developing a new medical device, you spend a bunch of time learni...

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