The Medical Device Innovation Consortium (MDIC) has announced the release of its Leadership Engagement Playbook of best practices and tools to help leaders move their companies from a culture of ...
Medtronic has tapped Scott Cundy, a regulatory official from one of the industry's largest life sciences companies, as its new chief quality officer. The move comes in the wake of the ...
On October 1, 2024, the Food and Drug Administration (FDA) marked a major milestone in medical device cybersecurity enforcement. This marks one year since the retracted Refuse to Accept (RTA) policy ...
The US Food and Drug Administration (FDA) published its Medical Devices; Quality System Regulation Amendments proposed rule to amend the medical device Quality System Regulation (QSR) on February 23, ...
Medical device equipment manufacturers work in an environment where product quality isn't just a competitive advantage, it's a regulatory necessity with direct implications for patient safety. As ...
We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
In the highly regulated field of medical device labeling translation, ensuring that every translated word meets both linguistic and regulatory requirements is critical. A company specializing in ...
We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
FDA has previously released guidance on medical device cybersecurity, but it never really had teeth – until now. Late last year, President Joe Biden signed a $1.7 trillion omnibus appropriations bill ...
On February 22, 2022, the Food and Drug Administration (FDA) proposed a long-awaited rule to amend its Quality System Regulation (QSR), which is codified at 21 CFR Part 820 and sets forth current good ...
BORDEAUX, France--(BUSINESS WIRE)--FineHeart S.A, a preclinical medical device company that has developed the ICOMS FLOWMAKER®, a fully Implantable Cardiac Output Management System designed to address ...
CHICAGO, June 22, 2020 /PRNewswire/ -- Echo Global Logistics, Inc. (NASDAQ: ECHO), a leading provider of technology-enabled transportation management services, has earned ISO 9001:2015, ISO 13485:2016 ...
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