MEDdesign

Outside the Surgical Suite:
Robotic Solutions on the Battlefield and Beyond

By Gianluca De Novi, Ph.D., XSurgical

Are remote laparoscopic and open surgical procedures on the horizon?

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.

FDA Issues Emergency Use Authorization for Hologic
and LapCorp COVID-19 Tests

By MedTech Intelligence Staff

The agency will continue to work with companies developing diagnostics relevant to the coronavirus outbreak in an effort to rapidly bring technologies to market.

FDA Issues Guidance to Speed Up Availability of COVID-19 Diagnostic Tests

By MedTech Intelligence Staff

Due to the public health emergency, the agency is implementing the guidance document immediately, without public comment.

Featured Quote

Modern drugs and technology alone do not automatically help patients to reach their therapy goal.

— Rolf Hinzmann, M.D., Ph.D, Roche Diabetes Care

Soapbox

Capitalizing on Standardized International Product Data

By Remco Munnik,
Iperion Life Sciences Consultancy

The latest regulations for human and veterinary medicinal products, as well as medical devices, include the mandate to set up databases with detailed information about available products. These databases must be realized and implemented in the near future, and require a concerted effort now if tangible real-world benefits are to follow.

PwC Report:
Value and Volume of MedTech Deals Could Rise This Year

By MedTech Intelligence Staff

Analysts expect 2020 to be a busy year for M&A activity.

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