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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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Mike Richman

FDA Compliance

Inside Quality Digest Live for November 30, 2018

Three great guests

Published: Friday, December 7, 2018 - 13:03

One of our favorite things on our show is to welcome guests, either via Skype or live in the studio. And this week, we were joined by three of our great partners. Here’s a closer look:

Interview: Nicole Radziwill of Intelex

Radziwill is quality manager and data scientist along with the presenter of the upcoming webinar, “SPC and FMEA: Integrating Systems Thinking Into Your Quality Architecture to Drive Improvement.” In this interview, she discusses how to utilize tools to drive quality outcomes for organizations.

Interview: Dan Jacob of LNS Research

Jacob is a research analyst and a perceptive student of quality trends. In this interview, he talks about the state of quality 4.0 initiatives for those within the all-important life sciences sector.

Tech Corner: iWave2 Handheld Wireless Gauge with AR

In this unique Tech Corner demo, Dirk chats with Matteo Zoin, senior manager and head of new market development for Marposs, about the company’s iWave2 handheld wireless gauge with augmented reality technology.

Our next episode of Quality Digest Live comes to you next Fri., Dec. 7, 2018. You can watch either via our home page or our special player page. See you then!

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Mike Richman