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MedTech Intelligence

Volume 10 Issue No. 11

Business Analysis Combination Products Market Access Operations Product Development Quality/Regulatory
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Featured Articles

Bang Chau, InnovitEmbrace the Healthcare Data Transformation

By Bang Chau, Innovit

Best practices to achieve compliance as regulations evolve and customer requirements change.

 
 

TheranosSEC Charges Theranos CEO Elizabeth Holmes with Fraud, Stripped of Control of Company

By MedTech Intelligence Staff

The disgraced company founder Holmes and its former President Sunny Balwani have been charged with raising more than $700 million from investors in a massive fraud scheme.

 
EU MDR & IVDR Update

Brian Moan and Norman Rabin, MaetricsIVDR signals In Vitro Industry Shake-up

By Brian Moan and Norman Rabin, Maetrics

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

New EU MDR RegulationsEU MDR Regulations & Revamp of the Medical
Device Directive

By Shilpa Gampa, Freyr

An overview of the key impact points and challenges of European Union Medical Device Regulation.

Peter Rose, MaetricsThe New MDR:
Opportunity Knocks

By Peter Rose, Maetrics

A look at the practical implications of the regulations, the market opportunity and tips for compliance.

 

Olympus, Fujifilm and Pentax Warned by FDAOlympus, Fujifilm and
Pentax Warned by FDA for Compliance Failures

By MedTech Intelligence Staff

The duodenoscope manufacturers didn’t comply with requirements to conduct postmarket surveillance studies assessing reprocessing effectiveness.

Devine Guidance

Christopher Devine, Ph.D., Devine Guidance International Duodenoscopes Take Two

By Christopher Devine, Ph.D.,
Devine Guidance International

Failure to comply with FDA’s wishes landed three companies warning letters.

 

More Articles »

MedTech Regulatory Summit - June 6-8, 2018 - Rockville, MD

Upcoming Events & Webinars

April 2018April 3-5, 2018 - MDTX - Medical Device Technology Exchange
Secaucus, NJ

May 2018May 1-2, 2018 - Medical Cybersecurity: Vulnerability & Patch Management
Washington, DC

May 2018May 14-15, 2018 - Medical Device Recalls: Current Topics & New Initiatives
Washington, DC

Jun 2018June 6-8, 2018 - MedTech Regulatory Summit
The United States Pharmacopeial Convention - Rockville, MD

Jun 2018June 26-27, 2018 - Developing Appropriate Medical Technology
Carolinas HealthCare System - Charlotte, NC

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