Our latest COVID-19 information/status - including self-paced online learning from our training partner Falconbury
  • Home
  • Courses
  • Vigilance

Courses

Vigilance

This seminar provides a detailed introduction to the European medical device legislation. It will explain the Regulation and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do.

An Introduction to the Medical Device Regulation

11-13 Nov 2020

Also on: 12 May 2021

Practical guidance on borderline Issues and combination products

This conference provides a unique opportunity to meet competent authorities, notified bodies, lawyers, consultants and manufacturers to understand and discuss the regulatory and legal requirements with respect to post-marketing surveillance including vigilance.

This two-day seminar will clarify the requirements applicable to in-vitro diagnostic devices under the IVD Regulation (EU) 2017/746. It will highlight the major changes to responsibility and product data expectations and will review the impact to industry.

An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow-up requirements and adverse event and vigilance reporting.

Managing the transition to the new regulation: this is a seminar you cannot afford to miss as you put in place your strategies for the new environment.

New Medical Device Regulation

19-20 Oct 2020

Also on: 17 Mar 2021

A practical five-day course with interactive workshops – now in its 17th successful year!

This comprehensive course has been designed to map the processes from device concept to marketing and show how regulatory, quality, clinical and other aspects of device development are joined into a continuous process.