General Medical Devices Training

Description
Regulatory

Clinical investigations with medical devices, where to start? This half-day course will focus on:

  • The basics of the medical device EU and US regulatory framework,
  • ISO14155 standard
  • Medical device definitions & classifications
  • Medical device life cycle and the importance of clinical investigations
  • The different stakeholders involved in device clinical investigations and their responsibilities.

At the end, you will receive a certificate for attendance and a copy of the course slides.

Learning objectives

By the end of this TRIUM Training you should be able to:

  • List the regulatory framework for clinical investigations with medical devices
  • Explain the role of clinical investigation in the development of devices
  • Identify the stakeholders involved and explain their role in clinical investigations with medical devices
Intended audience

Fundamental Level
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.

Trainer
Stefan Hosten
Stefan Hosten is a Clinical Research Professional and owner of Clinops Consulting with over 23 uears of experience in the field. Since 2001 he exclusively focusses on medical devices in all its aspects: field technique support, surgeon implant training, senior project management, European and US Medical Device legislation training and strategic advise to medical device start-up companies.