MedTech Intelligence Volume 10 Issue 46

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	Volume 10 Issue No. 46

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

EU MDR Compliance Cost EU 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 Selection Optimize 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, Intertek Countdown 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.

Featured Quote

Progressive device companies are starting to understand the limitations of traditional marketing and sales in favor of more holistic approaches to product development and sales. During this highly dynamic time there are opportunities to better understand and leverage knowledge of providers to more effectively serve customers.

— Patrick Vega, Vega Healthcare

Soapbox

Ale Brown, Kirke Management Consulting Creating 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.

Kalypso - Achieve Market Advantage While Streamlining Regulatory Compliance - Download Whitepaper

Save the Dates! - EU MDR Implementation Strategies Workshop - November 27-28, 2018 - Washington DC

Madge Tech - The Data Logging Difference in the Medical Industry

Resource Centers

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

Medical Device Audits, Certification & Verification
Quality & Regulatory Market Access Solutions
sponsored by UL
Medical Device Component
sponsored by 3M
Medical Recall

Sponsored Resources

The science of skin – just say no to MARSI

Understand adhesive safety concerns

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Learn more in our Science of Skin video series.

Upcoming Events & Webinars

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

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

January 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