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This Week in Quality Digest Live
FDA Compliance Features
Stephen McCarthy
Data-driven decisions are only as good as the data that drive them
Jennifer Lopez
How manufacturers can best prepare as the FDA moves to adopt ISO 13485:2016
Stephanie McArdle
The agency seeks to balance expedient exemptions against public transparency about medical devices
Grant Ramaley
European MDR update: Lowest risk medical devices must comply by May 26, 2020
Jon Speer
Lessons from the medical device industry

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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 Nov. 16, 2018

ISO vs. FDA audits, Baldrige winners, and what we can learn from GE

Published: Wednesday, November 28, 2018 - 13:02

In this episode we look at lessons learned (or not) from GE, the difference between ISO and FDA “requirements,” and this year's Baldridge recipients.

“GE’s Lessons Won’t Determine Whether You Succeed or Fail”

Does the success or failure of GE’s CEO really matter that much when it comes to how most of us lead, manage, and plan each day? Not necessarily.

“Top Five Things Life Science Companies Need to Know About ISO and FDA Requirements,” an interview with Matthew Lowe of MasterControl.

If the ISO standard says you “shall” do something you should do it; if the FDA says you “shall” do something, you really, really better do it.

“Five Role-Model Organizations Win 2018 Baldrige National Quality Award”

The U.S. Department of Commerce announced that the 2018 Malcolm Baldrige National Quality Award will be given to two educational institutions, an organ donor group, a hospital, and a project management firm.

 

Our next episode of Quality Digest Live comes to you this Fri., Nov. 30, 2018. You can watch either via our home page or our dedicated player page. See you then!

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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.