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

MedTech Intelligence

Volume 11 Issue No. 15



Kenneth MacCallum, Starfish MedicalUsing Agile Values for Medical Device Development

By Kenneth MacCallum, Starfish Medical

Although designed for software, Agile’s fundamental values are equally relevant to medical devices.

Featured Articles

Medical Device Cybersecurity Conference - June 4 - 5, 2019 - Boston, MAMedical Device Cybersecurity Conference to Address Vulnerabilities Facing Manufacturers and Hospitals with Legacy Devices

By MedTech Intelligence Staff

The vulnerability of legacy devices and systems can threaten patient safety and data privacy. Learn how to face these issues head on at this upcoming event.

Stephanie Domas, MedSecSpeaker Spotlight:
MedSec’s Stephanie Domas on
State of Cybersecurity

By Maria Fontanazza, Editor-in-Chief

Domas to share her insights at the MedTech Intelligence Cybersecurity conference in June 4–5 in Boston.


Jan Mansour, EAS Consulting Group, LLC510(k) Guidance Shifts Away Substantial Equivalence in Favor of Performance Testing and Criteria

By Jan Mansour,
EAS Consulting Group, LLC

This new pathway is a considerable change for the medical device industry.


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.

Medical Device Recalls Conference - June 24 - 25, 2019 - Washington, DC

3M - Learn the science of sticking to skin

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

MedTech M&A Conference - October 23-24, 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.

EU MDR Virtual Workshop Series

Sponsored Resources

Crescent IndustriesObtaining an Accurate Proposal for Injection Molded Tooling and Parts

Anyone can use this list as the basis of an RFQ checklist for future injection molded projects. The more complete and accurate the information given to the injection molders is, the more accurate and reliable their proposals will be, and the more likely production of the part or parts will run on schedule, efficiently and cost-effective. This article discusses specific tips OEMs can put into practice to ensure all competing quotes they receive will be accurate and comparable.

Click to Download White Paper.


3MScience of Skin: Skin Through the Ages - White Paper

Skin is the boundary between who we are as we present ourselves to the world while acting as the barrier to the insults that we experience in our day-to-day existence. Skin is the largest organ in the body and as such it is critical to the maintenance of our bodies. If we suffer damage to our skin, we can suffer a loss of function.

Access White Paper here

Upcoming Events & Webinars

May 20-21, 2019 - EU MDR Supply Chain & Economic Operators
A Virtual Conference

May 21-22, 2019 - EU MDR Clinical & Postmarket Surveillance Strategies
A Virtual Conference

May 23-24, 2019 - EU MDR Labeling, IFU, UDI, & Eudamed
A Virtual Conference

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

June 24-25, 2019 - Medical Device Recalls: Current Topics & New Initiatives
Washington, DC

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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