Requirements & processes for the development of medical devices & IVDs

This in-house training provides an insight into regulatory requirements and processes for successful product development. What elements must development projects include to ensure timelines and budgets are met while regulatory requirements are considered from the very beginning?

The seminar contents

Regulatory Requirements

  • Regulatory Background – EU Regulations for Medical Devices and In Vitro Diagnostics
  • The GHTF Regulatory Model
  • FDA – QSR: Design Controls

Processes for Medical Device Development

  • Project management
  • Quality Assurance in Development
  • Subprocesses in the Development Workflow
  • From Requirements Management to Design Transfer
  • Supporting Development Processes
  • Where can support, useful resources, and websites be found?
  • Do’s and Don’ts – Unwritten Laws
  • User experiences: Usability, process validation

Costs

1-day in-house training: EUR 3,890 (excl. VAT) for up to 10 participants
including seminar materials and participant certificate, plus travel expenses.

your trainer

DI Martin Schmid, Managing Director & Senior Consultant at en.co.tec
Information about our trainers

Book now:

Please send your request to seminare@encotec.at or call us: +43 1 8863491 +43 1 8863491