Tag: medical device development


Medical Device Development: Pathways to Clearance or Approval in the U.S. and Europe

Introduction Although medical device development is similar in many ways to drug development, devices are subject to different regulatory requirements and approval pathways than drugs. There are also key differences in the rules for the clinical investigations needed to support marketing approval, in part due to the durable nature of devices, which may be implanted...

Clinical Research: Phase 1 - Phase 4

5 Stages of Medical Device Development

While in many ways similar to pharmaceutical drug development, medical device development must work through some unique challenges, including: Variations in complexity — Devices may have multiple different constituent parts, including hardware, software, and medicinal components. Very different purposes — Almost all drugs are therapeutic, while devices may be therapeutic, diagnostic, monitoring, supportive, surgical, and more. Regulations regarding...