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. Our Autumn schedule is now in place, with options for attending online webinar-based courses.
An Introduction to the Medical Device Regulation Training Course
11-13 Nov 2020 - London & Online webinar
Also on: 12 May 2021
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.
Drug/Device and Device/Drug Combinations in the EU (European Union) and USA Training Course
24-25 Sep 2020 - London & Online webinar
Practical guidance on borderline Issues and combination products
EC Medical Devices Vigilance System and Post Marketing Surveillance Training Course
26-27 Jan 2021 - Online webinar
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.
Introduction to the In-Vitro Diagnostic Regulation (IVDR) Training Course
3-4 Nov 2020 - London & Online webinar
Also on: 11 May 2021
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.
Medical Device Studies: Regulatory Requirements and Adverse Event Reporting Training Course
22-23 Sep 2020 - London & Online webinar
Also on: 23 Feb 2021
An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow-up requirements and adverse event and vigilance reporting.
New Medical Device Regulation Training Course
19-20 Oct 2020 - London & Online webinar
Also on: 17 Mar 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.
The Medical Device Summer School - From Concept to CE Marking Training Course
5-9 Jul 2021 - Online webinar
*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.