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

Training & Courses:
Vigilance

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.

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.

The training was PHENOMENAL and I have learned so much regarding various topics in the field.

Anthony Hugill, Clinical Safety Specialist, Novocure

The content was very good, the presentation was comprehensive and the speakers were knowledgeable and confident.

Brigitta Lupsa, Marketed Product Support Team Leader, Owen Mumford Ltd

Excellent course which give a deep insight into the IVDR regulation without overloading with too much detail.

Jason Reece, CTO, Genomtec

Very knowledgeable speakers. The content was excellent, it is a difficult task to try and squeeze so much information into just three days!

Sarah Coverdale, Regulatory Affairs Specialist, Robinson Healthcare Limited

Janette was very knowledgable and enthusiastic and was able to keep the subjects interesting throughout the whole meeting. The content was very relevant.

Liselotte Borup, Clinical Trial Manager, Oticon Medical

The course gave me a good overview of the MDR and the reporting of adverse events: the content was good, the presentations were clear and the speaker was very good. She was open to questions, which she answered in the best way possible.

Valérie Jean, Senior Clinical Research Associate, Spineart SA

The speakers were clearly very experienced people from the industry and it was a huge privilege to meet them in person. I can definitely say that I know more now than I did three days ago and I can utilize this knowledge in my work. Also, it was good to see and meet other candidates who were from different work background and the challenges they faced.

Pranil Patil, Regulatory Compliance Specialist, Becton Dickinson

Thoroughly enjoyable and highly recommended. This course gave me a great foundation for vigilance and for someone who does not have a vigilance background it was great to learn the basics and the processes. The course was very well organized, there were plenty of opportunities for engagement and the speakers were all very knowledgeable.

Pardeep Kaur Sidhu, Post Market Surveillance Specialist, Quality, BECTON DECKINSON

All the speakers were absolutely excellent. I liked the fact that questions were invited and the chance to clarify with CAs and NB representatives.

Sarah Coverdale, Regulatory Affairs Specialist, Robinson Healthcare Limited

An enjoyable and insightful course. Good discussions and real-life examples and the exercises were worthwhile and interesting.

Tracey Jacob, Project Manager, Team Consulting