Regulatory requirements for medical equipment

Michael L. Marcus, Brian R. Biersach

Research output: Contribution to journalArticlepeer-review

7 Scopus citations


Medical equipment is highly regulated and held to a higher level of safety than nearly all other types of equipment on the market. Understanding the certification and regulatory requirements before the design phase of the equipment is expected to result in a cost reduction in equipment development, faster certification turnaround, and increased product safety.

Original languageEnglish (US)
Pages (from-to)23-29
Number of pages7
JournalIEEE Instrumentation and Measurement Magazine
Issue number4
StatePublished - Dec 2003

All Science Journal Classification (ASJC) codes

  • Instrumentation
  • Electrical and Electronic Engineering


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