The vigilance and post marketing surveillance requirements of the regulations applicable to medical devices, is a mechanism for the UK, European and FDA regulatory agencies and manufacturers to identify and monitor adverse events involving medical devices. The goals of the regulation are to detect and correct problems in a timely manner with patient safety as priority. Our training courses will provide participants with essential information to comply with the vigilance and post marketing surveillance requirements for medical devices.
Our spring/summer 2020 programme of London-based courses has been cancelled due to the COVID-19 outbreak. We are taking bookings for our Autumn events, but we are also working to deliver courses and content online. Please contact us if you are interested in an on-site or online version of any of our courses, tailored to your company's needs.
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.
11-13 Nov 2020
Also on: 12 May 2021
Practical guidance on borderline Issues and combination products
24-25 Sep 2020
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.
3-4 Nov 2020
Also on: 11 May 2021
An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow-up requirements and adverse event and vigilance reporting.
22-23 Sep 2020
Also on: 23 Feb 2021
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.
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.