Bringing a connected medical device to market is a long and resource intensive process. Once connectivity is involved, having a functioning device is not enough.
To ensure that each device is designed, manufactured, and managed securely, companies must navigate a complex landscape of legislation, standards, and regulations in order to receive the coveted green light of market approval.
Read this brief for a rundown of FDA, NIST, IEC, IMDRF, and other organizations that must be adhered to along the road to successful market authorization.
You’ll learn about:
Key players in the compliance field
How regulations work to keep devices secure
Specific guidelines that have become today’s standards