PharmaPhorum, a leading authority on news and insights in the pharma industry, recently featured an editorial about new medical device regulations from David Gwyn, a Global Solutions Architect at AMPLEXOR.
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When it comes to the regulatory environment, AMPLEXOR’s David Gwyn, Global Solutions Architect, believes that medical device manufacturers have much to learn from the pharmaceutical industry when it comes to new medical device regulations. According to Gwyn, with the medical device industry being on the verge of “monumental change,” now is the time for medical device manufacturers to take a clue from their pharmaceutical counterparts when it comes to regulatory management.
What to expect from new medical device regulations
In a recent post on PharmaPhorum, Gwyn details ways in which the medical device industry can “piggyback” on pharmaceutical best practices when it comes to compliance and new medical device regulations. In an editorial, “The Great Regulatory Catch-up,” Gwyn outlines the ways in which medical device manufacturers have fallen behind—and how they can catch up. “Until now,” Gwyn says, “medical device manufacturers have been largely exempt from such controls, and have seen themselves in a different category.”
However, new medical device regulations will change this. Taking lessons from pharma, demands on which continue to grow each year, the medical device industry can catch up with the increasing regulations being placed upon them. “Through an internationally harmonized approach to identifying and describing medicinal products,” says Gwyn, “the industry aims to bolster pharmacovigilance activities, make it easier to locate and exchange product and substance information globally; promote reuse of data across different procedures and regulators; and generally streamline regulatory processes so that these become steadily less onerous for everyone concerned.”
PharmaPhorum is a leading authority on the happenings in the pharmaceutical industry, reporting the latest news, information about new medical device regulations, insights, and views about healthcare.
Anastasia Crane has worked in Content Marketing for more than five years, and specializes in topics from software as a service (SaaS) to construction and everything in between. She has a degree in English from the University of Colorado and has spent the last 10 years of her career honing her writing and communication skills.