FDA 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.

FDA’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.

We 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.

A 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.

Featured Quote

Taking a bare-minimum approach to meeting the eIFU requirements of EU MDR could mean missing an opportunity to improve transparency in healthcare.

— Charlie Kim, Soom

Soapbox

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 Emerge

By MedTech Intelligence Staff

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

Top 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

By MedTech Intelligence Staff

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

• Medical Device Audits, Certification & Verification
• Quality & Regulatory Market Access Solutions
  sponsored by UL
• Medical Device Component
  sponsored by 3M
• Medical Recall

EU 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