Tag: medical device development

Clinical Research: Phase 1 - Phase 4

5 Stages of Medical Device Development

Medical device development must address some unique challenges that have grown over the last decade due to increasing medical device complexity, a more complex regulatory framework catching up with the industry, and an established and variable standard clinical practice to compete with: These factors have a major impact on the medical device development cycle, which...

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...

Tag: medical device development

Clinical Research: Phase 1 - Phase 4

5 Stages of Medical Device Development

Consulting

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