Stay informed about medical device insights, issues and regulation with BSI webinars

The pace of change in the medical device industry is swift. As EU regulation evolves under MDR/IVDR, and as the UK begins to develop its own medical device legislation post-Brexit, staying informed is increasingly important.

BSI medical device webinars provide invaluable information and insight, from discussion of hot topics to detailed guidance on key sections of regulation. Find out more on the BSI website.

What do the medical device webinars cover?

BSI webinars provide comprehensive guidance on key developments in the medical device sector. From news on the latest regulations, to themes and topical issues such as the post-Brexit regulatory environment, BSI is a reliable source for concise, accurate and up-to-date information.

As well as expert insights and detailed breakdowns of key sections of regulation, coverage includes useful non-sector specific issues. This includes everything from health, safety, and wellbeing, to organisational resilience, risk, and business continuity management.

Live, or on-demand.

Webinars are available live, free of charge, often including a Q&A session at the end. After the event, webinars are available to watch on demand.

Let’s take a look at some of the recent highlights:

1. Medical Device Regulation (MDR) - recent webinars include:

• Periodic Safety Update Report (PSUR) and Vigilance under the MDR. The purpose of the PSUR, how it relates to other parts of the MDR, what has changed and what remains the same under the new regime, where can you look for further information?
• MDR Rule 14 Devices – conformity assessment process and documentation requirements for submissions. Practical considerations for transition planning, the MDR conformity assessment process (time and procedures), competent authority assessment and documentation requirements, EU competent authorities and the impact of Brexit.
• MDR: Lessons Learnt. A close look at the issues around Technical Documents and the MDR including common causes of delay and error, guidance for members on completing an MDR submission and advice on how to improve procedures.
• Overview and update with BSI’s Dr Jayanth Katta. Dr Katta spoke about MDR, and the Notified Body Overview. Providing an overview of progress in implementing the MDR, the impact on manufacturers, and temporary extraordinary measures introduced to address Covid-related disruption.

2. In Vitro Diagnostic Regulation (IVDR) - recent webinars include:

• IVDR: Lessons Learnt. An expert panel discussed the IVDR certification process, QMS audits, Technical Documentation assessments, Performance Evaluation and Clinical Evidence, with tips on making applications and performance evaluation requirements, and must-read notes for members on common pitfalls.
• IVDR: Clinical Performance Studies. IVDR has expanded stipulations for clinical performance studies. This webinar detailed how standards such as ISO 20916 can support organisations, setting out best practice

3. UK Medical Device Single Audit Program (MDSAP) and medical device standards - recent webinars include:

• Are you ready for the Medical Device Single Audit Program (MDSAP)? What is MDSAP for, how does it work and how does it fit with other certifications? What happens during the auditing process?
• Symbols to be used on labelling (ISO 15223) and information to be provided by the manufacturer (ISO 20417). Here members got a sneak preview of unpublished new and revised standards, giving an overview of the contents of the new standards and how they relate to current requirements.
• ISO 14971:2019 Risk Management for Medical Devices. Looking at a revised edition of ISO 14971 and detailing key changes within the updated standard. This webinar confirmed the unchanged parts, the reasoning behind the changes that have been made and explained to members about the creation of a new related standard, ISO/TR 24971.

If you missed any of these webinars, you can now catch up on demand. Or sign up to one of our free, upcoming webinars here.