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 2019

Also on: 13 May 2020

Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents

Practical Guidance on Borderline Issues and Combination Products

Book by 9 Aug to save
£200 / €280 / $312

This seminar will provide a solid foundation in the approval and clearance processes for medical devices in the United States including the underlying legal and regulatory requirements and the ‘general controls’ applicable to all devices.

FDA Approval Process for Medical Devices

16-17 Sep 2019

Also on: 31 Mar 2020

Book by 9 Aug to save
£200 / €280 / $312

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.

Learn how to prepare a Request for Proposal (RFP), evaluate and select the right CRO and establish procedures for vendor oversight for R&D projects you need to outsource

Managing Vendor/CRO/CMO Oversight

3-4 Oct 2019

Also on: 27 Apr 2020

Book by 23 Aug to save
£200 / €280 / $312

Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR

Medical Device Studies: Clinical Evidence

14-15 Nov 2019

Also on: 11 May 2020

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

Book by 16 Aug to save
£200 / €280 / $312

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

24-25 Sep 2019

Also on: 4 Mar 2020

Book by 9 Aug to save
£200 / €280 / $312

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.