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Brian Moan, Norman Rabin, Maetrics
March 14, 2018
Brian Moan, Norman Rabin, Maetrics
Soapbox

IVDR signals In Vitro Industry Shake-up

By Brian Moan, Norman Rabin
No Comments

Manufacturers must re-evaluate existing regulatory and compliance strategies to meet the new requirements.

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Dr. Christopher Joseph Devine, President, Devine Guidance International
November 16, 2017
Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

The DMR: It’s the Recipe, People

By Dr. Christopher Joseph Devine
No Comments

The DMR is nothing more than the recipe (a.k.a. secret sauce), while the DHR is documented evidence of compliance.

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Dr. Christopher Joseph Devine, President, Devine Guidance International
October 25, 2017
Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Dr. D Sees a Trend

By Dr. Christopher Joseph Devine
No Comments

There really is no excuse for receiving a Form 483 observation for management review.

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Emmanuel Garnier, Simmons & Simmons LLP
August 11, 2017
Emmanuel Garnier, Simmons & Simmons LLP
Soapbox

When Health-Related Apps Qualify as Medical Devices in the European Union

By Emmanuel Garnier
No Comments

According to the Advocate General’s interpretation of the Directive and related soft law (i.e., MEDEV guidelines), software allowing the prescriber to detect contraindications, drug interactions and excessive doses shall qualify as a medical device.

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Peter Rose, Maetrics
July 31, 2017
Peter Rose, Maetrics
Soapbox

A Smooth Route to the New Medical Device Regulation

By Peter Rose
No Comments

The new MDR introduces several changes that manufacturers must consider right away.

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Scott Gottlieb, FDA
July 14, 2017
Scott Gottlieb, FDA

FDA’s Innovation Initiative Aims to Prevent Regulatory Barriers

By MedTech Intelligence Staff
No Comments

The agency wants to modernize its regulatory processes and make them more efficient.

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Checkbox
July 5, 2017
Checkbox

Paperless Manufacturing: Five Key Benefits for Medical Device Manufacturers

By Sean O’Sullivan
No Comments

Going paperless can ultimately help companies focus on improving product quality and the end-user experience.

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Theranos
June 23, 2017
Theranos

Report: Theranos to Settle $140 Million Lawsuit with Walgreens

By MedTech Intelligence Staff
No Comments

The settlement is one of a few that the company has made within the past several months.

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Wearable Cloud, Medical Device Connectivity
June 16, 2017
Wearable Cloud, Medical Device Connectivity

FDA Sets Forth Digital Health Innovation Plan

By MedTech Intelligence Staff
No Comments

The initiative also focuses on how devices will be regulated in the post-market world.

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Scott Gottlieb, FDA
May 10, 2017
Scott Gottlieb, FDA

Scott Gottlieb Confirmed as FDA Commissioner

By MedTech Intelligence Staff
No Comments

The new commissioner was confirmed in a 57 to 42 vote.

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