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MedTech Intelligence

Volume 10 Issue No. 46

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

EU MDR Compliance CostEU MDR Cost of Compliance: The Results Are In

By Maria Fontanazza, Editor-in-Chief

Here's what companies think when it comes to how much it will cost to comply with the new regulation.

Featured Articles

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

By Brian Reilly, NuSil

Getting your requirements right early in the development process can help avoid problems during final manufacturing.

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.

Michael Murphy, IntertekCountdown for Compliance:
Electromagnetic Compatibility Requirements Under IEC 60601-1-2
4th Edition

By Michael Murphy, Intertek

With the evolution of medical electric technology, EMC concerns are crucial.



Ale Brown, Kirke Management ConsultingCreating an Effective and HIPAA-Compliant Data Management Strategy

By Ale Brown,
Kirke Management Consulting

The data that medical devices use is one of the most sensitive types of information.


More Articles »


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

Sponsored Resources

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Understand adhesive safety concerns

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Upcoming Events & Webinars

Nov. 2018November 27-28, 2018 - EU MDR Implementation Strategies Workshop
Washington, DC

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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