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MedTech Intelligence

Volume 10 Issue No. 48

Business Analysis Combination Products Market Access Operations Product Development Quality/Regulatory

How to Plan for EU MDRHow to Plan for EU MDR, So You Can Sleep at Night

By Sandi Schaible, WuXi AppTec

Learn about the implications of changes to ISO 10993-1 and the introduction of the MDR, stages of pre-clinical device testing, why chemical characterization is more important than ever before, and how device manufacturers can begin assembling the right team of testing experts to ensure their products are safe and ready for market.

Featured Articles

Ameing for Asia

Ames Gross, Pacific Bridge MedicalAugmented and Virtual Reality Make Inroads in Asia's Medtech Market

By Ames Gross, Pacific Bridge Medical

Digital reality technologies are fast emerging as promising tools to aid physicians and patients. Western and Asian medtech companies are becoming big players in the growing market for these new applications in Asia.

FDAFDA Commish and CDRH Director Announce Agency Actions to Enhance Patient Safety Using Data

By MedTech Intelligence Staff

The agency will be improving postmarket surveillance, looking at issues that come up once a device is on the market, and promoting innovation.

Optimize Production With the Proper Silicone Adhesive SelectionOptimize Production
With the Proper Silicone Adhesive Selection

By Brian Reilly, NuSil

Medical device manufacturers regularly use silicone adhesive solutions due to silicone’s biocompatibility and versatility. Determining your specific adhesive requirements early in the device development phase can save time later by avoiding unanticipated adhesion problems that can sidetrack the final manufacturing process.


EU MDRMost Popular Stories:
It’s All About EU MDR

By MedTech Intelligence Staff

The readers of MedTech Intelligence continue to crave any content that will help them learn more about the Medical Device Regulation.

Devine Guidance

Christopher Devine, Ph.D., Devine Guidance International Refused Entry into the
United States!

By Dr. Christopher Joseph Devine,
Devine Guidance International

When adulterated products are manufactured in a foreign establishment, don’t expect FDA to admit them into the country.


More Articles »


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Upcoming Events & Webinars

December 2018December 5, 2018 - 12pm EST - Neurotechnology: Advancing Beyond Expectations
Complimentary Webinar

JanuaryJanuary 23-24, 2019 - Advanced CAPA and Root Cause Analysis Workshop for Medical Device Companies
Washington, DC

JanuaryJanuary 29-30, 2019 - Medical Device Process Validation
A Virtual Conference

February 5-6, 2019 - EU MDR Remediation Strategy
Washington, DC

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

March 5-6, 2019 - Med Tech Import/Export
Washington, DC

March 7-8, 2019 - EU MDR Supply Chain & Economic Operators
Washington, DC

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

May 7-8, 2019 - Medical Device Cybersecurity: Legacy Device Remediation, Compensating Controls, & End-of-Life
Cambridge, MA

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, 2019 - Global Regulatory Strategy
Washington, DC

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