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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...

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,...

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...

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...

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...

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...

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...

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...