Volume 10 Issue No. 11
Embrace the Healthcare Data Transformation
By Bang Chau, Innovit
Best practices to achieve compliance as regulations evolve and customer requirements change.
Imagine a wearable device no larger than a watch that uses sensors to continuously measure white blood cell count and wirelessly communicate with the oncologist’s office.
— Ashutosh Sabharwal, Rice University
SEC 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.
IVDR 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.
EU MDR Regulations & Revamp of the MedicalDevice Directive
By Shilpa Gampa, Freyr
An overview of the key impact points and challenges of European Union Medical Device Regulation.
The 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 andPentax Warned by FDA for Compliance Failures
The duodenoscope manufacturers didn’t comply with requirements to conduct postmarket surveillance studies assessing reprocessing effectiveness.
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 »
Resource Centers are single topic focused micro-sites within MedTechIntelligence.com that are portals of information on medical device components and quality systems offering news, articles, white papers, case histories and videos.
April 3-5, 2018 - MDTX - Medical Device Technology ExchangeSecaucus, NJ
May 1-2, 2018 - Medical Cybersecurity: Vulnerability & Patch ManagementWashington, DC
May 14-15, 2018 - Medical Device Recalls: Current Topics & New InitiativesWashington, DC
June 6-8, 2018 - MedTech Regulatory SummitThe United States Pharmacopeial Convention - Rockville, MD
June 26-27, 2018 - Developing Appropriate Medical TechnologyCarolinas HealthCare System - Charlotte, NC