Medical Innovation Exchange

AdvaMed

Regulatory Advocacy: Amplifying Your Voice

Regulatory Advocacy: Amplifying Your Voice     Medical devices and pharmaceuticals are heavily regulated. In the U.S., stakeholders have opportunities to communicate with regulators through pre-submission meetings, commenting on proposed regulations and draft guidances, and working with industry trade associations. But what is the right path for your particular company or concern? During the 2023 MedTech …

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AdvaMed Warns EPA of Massive Interruption to Patient Care

AdvaMed Warns EPA of Massive Interruption to Patient Care     In comments filed with the Environment Protection Agency (EPA), industry association AdvaMed called for continued cooperation between the medical device industry and the EPA as the regulations covering medical device sterilization using ethylene oxide (EtO) move forward. AdvaMed said if the proposals are finalized as …

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EPA Announces Proposed Rules To Reduce Ethylene Oxide Exposure

EPA Announces Proposed Rules To Reduce Ethylene Oxide Exposure     On April 11, the Environmental Protection Agency (EPA) proposed new health protections to reduce exposure to Ethylene Oxide (EtO). These include a proposed rule regulating ethylene oxide (EtO) sterilizers of medical technology and other commercial uses through the National Emission Standards for Hazardous Air Pollutants …

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Qiagen CEO Named Chair of AdvaMedDx Board of Directors

Qiagen CEO Named Chair of AdvaMedDx Board of Directors     Thierry Bernard, CEO of Qiagen has been elected Chair of the AdvaMedDx Board of Directors. AdvaMedDx is a division of AdvaMed representing more than 75 manufacturers of in vitro diagnostic (IVD) tests and technologies in the U.S. and abroad. Bernard joined Qiagen in 2015 and …

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