Navigating Changing Regulations for Diagnostic Testing Organizations

As US-based diagnostic organizations capitalize on the increasing world-wide interest in testing, they need to understand the regulatory landscape in different markets.

The European Union's (EU) In Vitro Diagnostic Regulation (IVDR) of Medical Devices 2017/746 is significantly affecting the IVD industry and companies selling into the EU market as they get ready to meet tougher medical device compliance requirements.

The biggest change is the introduction of a risk-based approach to classification in addition to increased NB oversight.

Learn how Allied and our partner Titan Solutions are addressing these challenges and creating successful outcomes for our clients by checking out our article IVDR: What You Need to Know about Europe's Changing IVD Market

About Author
Brian Butler
Brian Butler

Brian Butler is vice president of business development for The Allied Group, a leading provider of marketing and fulfillment programs for the life science, healthcare, education and financial services industries. He is the author of two books, Find ‘Em, Get ‘Em, Keep ‘Em—Proven Strategies for Attracting, Acquiring and Retaining the Right Customers and the recently released In Search of…Customers!, both published by Outskirts Press. Brian has given numerous keynote addresses and presentations for organizations that include AARP, IBM, One Communications, and Atlas Travel International. He holds a BS in marketing from The University of Bridgeport, where he attended school on a two-sport athletic scholarship, and an MBA from Century University. He is a lifelong resident of Rhode Island.

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