Meet...

Stuart Angell

Presenter

Stuart Angell is a joint director in his own consultancy specialising in global regulatory affairs strategy and compliance for in vitro diagnostics and medical devices focusing on the transition to the new IVD/Medical Device Regulations, MDSAP and ISO13485:2016.

He has over 15 years in the IVD industry and in previous roles has been responsible for designing, reviewing and maintaining regulatory frameworks for self-declared and annex list II products including technical documentation for EU and global submissions (FDA, Health Canada, TGA, Russia, Latin America). He has an excellent understanding of risk management, Post Market Surveillance (PMS) and vigilance.

Stuart Angell’s courses

Reviews for Stuart’s courses

Objective: to get a better understanding of MDSAP requirements was well met by training. Very well put together and delivered. The presenters came across very knowledgeable and experienced, and valuable insight was shared through group discussions. I really liked the structure and pace of the course, and it was suited to my needs.

10 Jul 2025

Medical Device Single Audit Programme (MDSAP)

I accomplished a better understanding on the role of the PRRC. Very knowledgeable [speaker] with a good presentation style.

22 May 2025

The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR and IVDR

The presentation was outstanding. The presenters were welcoming. The session was interactive and insightful.

5 Feb 2025

Introduction to the In-Vitro Diagnostic Regulation (IVDR)

The training successfully addressed Learning more about the role and responsibility of the PRRC. Content and presentation all good. Not too formal, not too informal. Just right. Speakers [have] Great knowledge about the subject.

23 Jan 2025

The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR and IVDR

Good content [particularly liked] MDR requirements.

23 Jan 2025

The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR and IVDR

Good Content. Presentation/Speakers - 5* Very good.

23 Jan 2025

The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR and IVDR

The content was structured logically and could be followed easily. The atmosphere was friendly and inviting to participate/ask questions. [Speakers were] competent, very helpful, friendly and patient with us.

23 Jan 2025

The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR and IVDR