The Safe Medical Devices Act of 1990 requires medical device user facilities (i.e., hospital, ambulatory surgical facility, nursing home, or outpatient treatment facility) to notify any suspected death, serious illness, or injury to the U.S. Food and Drug Administration (FDA) and manufacturer. It is designed to protect the public by ensuring that medical devices are not unsafe for their intended use.
*Source: https://www.congress.gov
The MEDDEV Guidance Documents are created on behalf of the European Commission by several working groups to help stakeholders in implementing medical device directives. The MEDDEVs encourage manufacturers and notified bodies involved in conformity assessment procedures to have a common approach.
*Source: https://akrnconsulting.com
Regulatory affairs professionals in the medical device industry are responsible for leading premarket strategy, drafting regulatory submissions, and ensuring post-market compliance.
*Source: https://www.northeastern.edu
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