EU MDR Workshop Series -

MedTech Intelligence

Volume 11 Issue No. 06



Charlie Kim, SoomKeep Calm and Carry On...
And Other Outlooks We Can Apply to MDR Implementation

By Charlie Kim, Soom

With just over a year remaining before the EU MDR and IVDR regulations go into effect, many in the medical device industry are shifting their compliance efforts into high gear—a somewhat tedious task given the industry is still waiting on functional specifications for Eudamed.



Featured Articles

StrykerStryker Initiates Voluntary Field Correction for LIFEPAK Monitor/Defibrillator,
Six Deaths in Ten Years

By MedTech Intelligence Staff

The device has been exhibiting a lockup condition during patient use, leading to potential serious injury or death.

Maria Fontanazza, Editor-in-ChiefM&A: Once the Deal Closes, What Should I Do?

By Maria Fontanazza, Editor-in-Chief

Look for the good, the bad, and the ugly, but above all, look for anything that affects patient safety.

Jacob Krive, Ph.D., University of Illinois, College of Applied Health SciencesIs the Healthcare Industry Ready to Embrace a Consumer Wearable
Device Revolution?

By Jacob Krive, Ph.D.,
University of Illinois,
College of Applied Health Sciences

The success of these technologies also relies on simplification to target certain patient populations, ensuring secure data transmission, and that operational models are built to make effective use of the data.

FDARecent FDA Action:
Three Recalls and Ten Medical
Device Approvals

By MedTech Intelligence Staff

The device approvals address critical patient need.

Infographic: Radiation ScienceRadiation Science:
Breakthroughs That Change Lives

By Sarah Daren, Freelance Writer

Today, some of the most exciting medical advancements are in digital imaging.

Sponsored Content

Crescent IndustriesInjection Molding Supply Chain Solutions to Reduce Complexity

Consolidating your supply chain has been the goal of many OEM’s for the past 15+ years and suppliers continue to evolve with the market demands to provide more than solely their core competency as a solution. Crescent Industries expanded their capabilities to not only offering full assembly using automation expertise but also managing the complete supply chain with some projects having over 20 components.

Click to read, complete blog article on Supply Chain Solutions to Reduce Complexity.

3M - Learn the science of sticking to skin

Advanced CAPA & Root Cause Analysis Conference - March 26-27, 2019 - Washington, DC

MedTech Import/Export Workshop - April 15 - 16, 2019 - Washington, DC

Medical Device Recalls Conference - May 21-22, 2019 - Washington, DC

Resource Centers

Resource Centers are single topic focused micro-sites within that are portals of information on medical device components and quality systems offering news, articles, white papers, case histories and videos.

Medical Device Cybersecurity Conference - June 4 - 5, 2019 - Boston, MA

Upcoming Events & Webinars

March 2019March 5-6, 2019 - EU MDR the Cost of Compliance: Assessing Infrastructure and Resource Impact
Washington, DC

March 2019March 6-7, 2019 - EU MDR Clinical & Postmarket Surveillance Strategies
Washington, DC

March 2019March 26-27, 2019 - Advanced CAPA & Root Cause Analysis
Washington, DC

April 15-16, 2019 - MedTech Import/Export: Regulations, Procedures, Best Practices
Washington, DC

April 16-17, 2019 - EU MDR Supply Chain & Economic Operators
Washington, DC

April 11-12, 2019 - EU IVDR Implementation
Washington, DC

May 21-22, 2019 - Medical Device Recalls: Current Topics & New Initiatives
Washington, DC

May 23-24, 2019 - EU MDR Labeling, IFU, UDI, & Eudamed
Washington, DC

June 4-5, 2019 - Medical Device Cybersecurity: Legacy Device Remediation, Compensating Controls, & End-of-Life
Boston, MA

OctoberOctober 22-23, 2019 - Global Regulatory Strategy
Washington, DC

OctoberOctober 23-24, 2019 - MedTech M&A: Regulatory & Quality Due Diligence
Washington, DC

NovemberNovember 13-14, 2019 - India - the MedTech Market: Strategic Planning & Practical Considerations
Washington, DC

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