What is the proposed FDA order for AEDs and what does it mean to medical technology manufacturers?
In our initial post on the proposed FDA order on automated external defibrillator systems (AED) manufacturers, we spoke with Dan Matlis, president of…
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The Food and Drug Administration (FDA) is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following class III pre-amendments devices: automated external defibrillator systems…
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One of the principal reasons regulatory compliance is such a central issue in life sciences is the penalty paid for non-compliance. The consequences can be severe. Serious risks exist at both revenue and operational levels.
If the non-compliance is early,…
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FDA Proposed Order on AED Manufacturers: Part Two
May 17, 2013
FDA Proposed Order on AED Manufacturers: Part One
May 14, 2013
Why Non-Compliance Is a Frightening Prospect for Life Sciences Organizations
May 9, 2013
More than Moore: MIT Study Looks to Improve Accuracy of Long-Term Forecasting
May 7, 2013
Podcast Episode 8: FDA Cracks Down on Suppliers/Purchasing Controls with AED Proposed Order
May 3, 2013
Technology Shakers Part 1: One Place for Manufacturing Data
January 8, 2013
Medical Device Excise Tax Strategy 1 – Eliminate the Fog of War
January 15, 2013
Time to Reassess Semiconductor MES
December 6, 2012
Decisions at the Speed of Innovation
February 7, 2013
Sequestration or Not, American Manufacturing Shines a Beacon of Hope
March 11, 2013
Mike Beunder says:
MES is only one part of the story. Today the puzzle...
Silvio Saouaf says:
You are absolutely correct, Julie. Having quick access to key...
Jody Cowan says:
Precisely right, Silvio. The ability to understand and control your...
Silvio Saouaf says:
There are some excellent comments here. How can you improve...
Silvio Saouaf says:
You're right, Jody. The use of visual cues and icons...
