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Getting Users to answer Post Market Surveillance Questionnaires: Tips for Manufacturers (AI created)
Post market surveillance is a critical aspect of the medical device industry. It involves monitoring the safety and effectiveness of...
arhekr
Feb 26, 20232 min read
What's up with the certification of Class IIb/III devices under the MDR?
End of May 2025, devices certified under the MDD can no longer be sold or distributed in EU - less than 28 months to go. Tick-tock,...
arhekr
Jan 30, 20231 min read
Medical Device Manufacturers: Align your Ducks and make MDR a Friend for Innovation
It's May 26, 2021 and seems that the sun is still shining somewhere behind the clouds despite much anxiousness regarding the new MDR...
arhekr
May 26, 20213 min read
The Art of making long Shadow spark Joy
Japanese companies are famous for taking their time in the initial phase of product development - pondering over every nook and cranny...
arhekr
Apr 27, 20212 min read
MDR/IVDR Post Market Surveillance Assessment
Arguably, two major incentives of revising the EU Medical Device Directive (MDD) with the upcoming Medical Device Regulation (MDR), are...
arhekr
Apr 21, 20212 min read
Reaching 15% Freedom to Innovate in the Medical Device Industry
Frank Gehry is perhaps best known as the architect behind the Guggenheim Museum in Bilbao and the Walt Disney Concert Hall in Los...
arhekr
Apr 13, 20213 min read
Catch-up or Overkill: Classification in the Time of MDR/IVDR
Classifying mushrooms into edible vs non-edible (or poisonous), can be a daunting task - most often ending as a pleasant meal, but...
arhekr
Apr 6, 20212 min read
Clockspeed and Modular Architecture in the Medical Device Industry
Clockspeed is a term coined by the MIT professor Charles Fine in the late 1990s. It describes the various rates of evolution in...
arhekr
Mar 31, 20211 min read
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