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This Week in Quality Digest Live
FDA Compliance Features
AssurX
Questions linger about FDA processes that seem to favor medical device companies
Matthew M. Lowe
Confronting the fear of being displaced by machines
Matthew M. Lowe
The velocity at which digital transformation is reshaping business models seems utterly chaotic in a compliance-based industry
Jon Speer
As a medical device manufacturer, you can expect to be inspected
Dirk Dusharme @ Quality Digest
Huge amounts of biometric, DNA, and diagnostic data enable personalized medicine. They also enable unscrupulous and discriminatory marketing.

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FDA Compliance News
Creates adaptive system for managing product development and post-market quality for devices with software elements
VQIP allows for expedited review and importation for approved applicants that demonstrate safe supply chains
An invite from Alcon Laboratories
Intended to harmonize domestic and international requirements
The FDA wants medical device manufactures to succeed, new technologies in supply chain managment
Pharma quality teams will have performance-oriented objectives as well as regulatory compliance goals
Strategic investment positions EtQ to accelerate innovation efforts and growth strategy
The FDA’s RMAT designation goes live

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Profiles in Quality: Mike Micklewright, Part 2 of 3

Video Information

This week, the second of three episodes with Mike Micklewright. In this week's episode, offshoring (or outsourcing), does it really save you money; are you taking a realistic look at the total cost?
 
 

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