The objective of clinical studies is to ensure that all medical devices provide clinical benefits to the patient, as well as providing the necessary data to comply with current regulations. Our clinical training courses have been designed to provide delegates with the tools and techniques required to design and develop a medical device, as well as giving delegates an overview of the current regulatory landscape.
An Introduction to the Design and Development of Medical Devices Training Course
12-13 Oct 2020 - London
Also on: 14 Oct 2020
A comprehensive introduction to the design and development of medical devices, including device constituent parts of combination products
An Introduction to the Medical Device Regulation Training Course
11-13 Nov 2020 - Online webinar
Also on: 18 Nov 2020
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.
Clinical Evaluation of Medical Devices: The Clinical Evaluation Report Training Course
1-2 Dec 2020 - Online webinar
Also on: 3 Dec 2020
Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents
Drug/Device and Device/Drug Combinations in the EU (European Union) and USA Training Course
22-23 Sep 2020 - London
Also on: 24 Sep 2020
Practical guidance on borderline Issues and combination products
FDA (Food and Drug Administration) Approval Process for Medical Devices Training Course
14-15 Sep 2020 - London
Also on: 16 Sep 2020
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.
Introduction to the In-Vitro Diagnostic Regulation (IVDR) Training Course
3-4 Nov 2020 - Online webinar
Also on: 5 Nov 2020
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.
Managing Vendor/CRO (Contract Research Organisation)/CMO (Contract Manufacturing Organisation) Oversight Training Course
Medical Device Studies: Clinical Evidence Training Course
Medical Device Studies: Regulatory Requirements and Adverse Event Reporting Training Course
22-23 Sep 2020 - 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 - Online webinar
Also on: 21 Oct 2020
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 - London
*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.