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MedTech Intelligence

Volume 12 Issue No. 12


FDAFDA Working to Increase U.S. Supply of Personal Protective Equipment and Devices

By MedTech Intelligence Staff

The agency has altered its import screening to accelerate the availability of PPEs.

Featured Articles

FDA’s Emergency Use Authorization Picking UpFDA’s Emergency Use Authorization Picking Up, at Least Seven COVID-19 Tests Available

By MedTech Intelligence Staff

Diagnostic companies are hustling to increase availability of testing for the novel coronavirus.

Mark Wasmuth, GMDN AgencyWe Need Better Data to
Make Better Decisions

By Mark Wasmuth, GMDN Agency

Sources of reliable data to continuously support claims of compliance by manufacturers will be in high demand in the future.

Medical Device SecurityA Prescription for Curing Connected Medical Device Security

By Vinay Gokhale, Thirdwayv

The more devices are connected, the more that targets are present for remote attackers.


Ryan Lewis, M.D., Advanced Sterilization Products, Inc.Preventing Contaminated Medical Devices in the Context of COVID-19

By Ryan Lewis, M.D.,
Advanced Sterilization Products, Inc.

During an outbreak, it is critical to treat reusable medical devices as potential sources of transmission.

Amidst COVID-19 Pandemic, Scams Involving Personal Protective Equipment EmergeAmidst COVID-19 Pandemic, Scams Involving Personal Protective Equipment Emerge

By MedTech Intelligence Staff

As the saying goes, if it looks too good to be true, it probably is.

Sponsored Content

Crescent IndustriesTop 5 Most Common Quality Defects for Injection Molded Products

Plastic injection molding is a practical method for mass production of parts. But even the best designs have shortcomings that result in product defects. These include flash, weld lines, sink marks, short shots, and burn marks. Be familiar with these potential problems to troubleshoot and avoid them. Read about each defect and ways to find a solution.

Call for Abstracts: MedTech Cybersecurity Conference

Call for Abstracts:
MedTech Cybersecurity Conference

By MedTech Intelligence Staff

The two-day event takes place September 22–23, 2020. Submit an abstract, or register to attend.

EU MDR Risk Management Web Series - April 6-7, 2020

Six Sigma Approach to CAPA Virtual Workshop - May 6 & 20, 2020

Resource Centers

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.

Sponsored Resources

EU MDR Web SeminarsEU MDR Risk Management Web Seminar

April 6-7, 2020

This two half-day virtual event features presentations and panel discussions by speakers from notified bodies and top medical device companies.

Topics covered:

  • Introduction and Overview - Risk Management and the EU MDR
  • ISO 14971:2019 – Overview and Applicability to EU MDR and other regions
  • Design and Usability Requirements with respect to EU MDR
  • Practical application of Risk Management for EU MDR
  • EU MDR and Post Market Surveillance Requirements
  • EU MDR additional Monitoring and Trending Requirements
  • Post Market Surveillance methods and best practices
  • Post Market Surveillance and Risk Management
  • Application of Risk Management for Post Market Surveillance and Trending
  • Tying it all together - EU MDR / Risk Management / Post Market Surveillance

Register Now at www.EU-MDR.events

Upcoming Events & Webinars

AprApril 6-7, 2020 - EU MDR Risk Management
Virtual Events

MayMay 6 & 20, 2020 - Six-Sigma CAPA Virtual Workshop
Virtual Events

SeptemberSeptember 22 - 23, 2020 - MedTech Cybersecurity Conference
Washington, DC

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