Introduction to

Medical Device Standards & Regulations

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Intro to Medical Device Standards & Regulations - hero (800)-1

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
    Key players in the compliance field

  • How regulations work to keep devices secure
    How regulations work to keep devices secure

  • Specific guidelines that have become today’s standards
    Specific guidelines that have become today’s standards

    Specific guidelines that have become today’s standards

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