Medical devices in the UK and EU have to undergo a conformity assessment to demonstrate to the regulatory agencies that they meet legal requirements to ensure they are safe and perform as intended. In the USA, medical devices are regulated by the Food and Drug Administration (FDA) with the aim to ensure safety and effectiveness of devices. Our training courses have been designed to provide participants with the necessary information to comply with the regulations in the UK, Europe and the USA.
Advanced Regulatory Affairs for Medical Devices Training Course
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.
Biological Evaluation of Medical Devices Training Course
25-26 Nov 2020 - Online webinar
Also on: 18 May 2021
Key guidance on how to use the ISO 10993 series of standards and successfully apply a risk management approach to the biological evaluation of medical devices.
*Includes:* Interactive workshops and discussion sessions
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
Cyber Security for Medical Devices Training Course
Development of Combination Products: Critical Interactions Training Course
17-18 Nov 2020 - Online webinar
Also on: 5 May 2021
Linking the technical requirements of device design and pharmaceutical product development.
Using QbD to deliver drug/device combinations.
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
Dry Powder Inhalers Training Course
EC Medical Devices Vigilance System and Post Marketing Surveillance Training Course
26-27 Jan 2021 - Online webinar
Also on: 28 Jan 2021
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.
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.
Human Factors and Usability Engineering in the Development of Drug Delivery Products Training Course
30 Sep-1 Oct 2020 - Online webinar
Also on: 23 Feb 2021
Applying HF and usability to comply with the MDR.
This two-day workshop has been designed specifically for product developers who want to incorporate human factors testing into their product development, or need to provide the regulators with specific usability data for their device.
Inhaled Drug Delivery Training Course
Injectable Drug Delivery Training Course
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.
Medical Device Regulation in the Eurasian Union, Russia and the CIS Training Course
7-8 Oct 2020 - Online webinar
Also on: 6 Oct 2021
A comprehensive overview of medical device regulatory affairs in Russia and the Eurasian Union. Key countries covered include Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan and Ukraine.
Medical Device Regulations in the Middle East and North Africa Training Course
30 Jun-1 Jul 2021 - Online webinar
Also on: 7 Jul 2021
This seminar will provide an essential overview of the key areas of requirements for product approvals for medical devices in the Middle East and North Africa.
*Covering Algeria, Bahrain, Egypt, Israel, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Palestine, Saudi Arabia, Sudan, Syria, Tunisia, UAE and Yemen*
Medical Device Software: Complying with the MDR (Medical Device Regulation) & FDA (Food and Drug Administration) Regulations Training Course
17-19 Nov 2020 - Online webinar
Also on: 24 Nov 2020
An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.
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.
Metered Dose Inhaler (MDI) Technology Training Course
Nasal Drug Delivery Training Course
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.
Technical Documentation to Comply with the MDR (Medical Device Regulation) and IVDR (In-Vitro Diagnostic Regulation) Training Course
29-30 Sep 2020 - Online webinar
Also on: 8 Mar 2021
This seminar will provide essential guidance on the content of the technical documentation file, the changes required and the practicalities of compiling and maintaining the technical file to comply with the MDR and IVDR.
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.