Georgia Tech Developing DIY Healthcare Gear
in Face of Shortages from COVID-19

By MedTech Intelligence Staff

The researchers speculate that they have about two weeks to “get it right” and scale up to meet the surge of patients expected to enter hospitals.

Battelle Gets FDA Emergency Use Authorization for
N95 Respirator Decontamination System

By MedTech Intelligence Staff

The system will allow healthcare professionals to reuse the critical care products up to 20 times during the COVID-19 pandemic.

Soapbox

How to Plan for and Navigate a Crisis with Purpose and Clarity

By Ayme Zemke,
Beehive Strategic Communication

Being prepared significantly improves the odds that an organization will successfully manage and mitigate risk, sustain trust and loyalty, and protect and preserve their brand.

Featured Quote

One of the most important issues facing the healthcare industry is the lack of global standards for data interchange, work processes and control capabilities.

— Alex Saric, Ivalua

Real Problems with Virtual Patent Marking

By Scott Simmonds,
Barnes & Thornburg, LLP

For medical device manufacturers, the American Invents Act created several challenges related to patent marking.

MEDdesign

On a Mission to Innovate

By Martin Gerber,
Ascensia Diabetes Care

Innovation requires the space for failure and continuous improvement.

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