North America
The FDA, the regulating authority in the sphere of medical device circulation of the United States, issued guidance providing additional information on new pilot conformity assessment procedures. ASCA: key points The Accreditation Scheme for Conformity Assessment...
North America
Health Canada, the Canadian medical regulating authority, announced that new requirements, which was under development since 2018, came into effect this week. The scope of new requirements covers issues related to cybersecurity threats. In accordance with applicable...
North America
The medical device regulating authority in the United States, the FDA, issued special warning on cybersecurity threats related to cardiac implantable devices (ICDs). According to the document placed on the official website, the FDA aims to alert both companies and...
Consultant Post
Dealing with FDA deficiency letters doesn’t have to be hard, read on to find out how best to address your deficiencies.
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