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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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Dirk Dusharme @ Quality Digest

FDA Compliance

Inside Quality Digest Live for Oct. 27, 2017

Cost-cutting at Ford, compassionate-use drugs, and innovation stagnation

Published: Tuesday, October 31, 2017 - 10:58


Our Oct. 27, 2017, episode of QDL looked at Ford, autonomous cars, and changes to FDA compassionate use rules.

“Ford Plans $14B in Cost Cuts as Part of New CEO’s Strategy”

Ford Motor Co’'s new CEO plans to cut $14 billion in costs, drop some car models, and focus the company’s resources on trucks, SUVs, and electric vehicles as part of a renewed effort to win over skeptical investors.

“FDA Eases Application Process for Compassionate Use”

The FDA recognizes that time is critical for seriously ill patients who do not have alternative therapies.

“Nobody Wants You to Be Creative”

Innovation threatens established beliefs.

“When Cars and Stoplights Confer”

Governments and automakers must resolve competing goals for self-driving cars.

Off script: What’s really important for the longevity of a company?

Catch us again for another episode of Quality Digest Live this coming Fri., Sept. 3, 2017. You can watch us either on our home page or our dedicated player page. See you there!

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About The Author

Dirk Dusharme @ Quality Digest’s picture

Dirk Dusharme @ Quality Digest

Dirk Dusharme is Quality Digest’s editor in chief.