With the upcoming EU regulatory changes for IVDs, it’s important to keep informed about the changes so you can prepare your business. We know your time is important and sometimes there are only a few minutes between meetings to catch up on information that is important to you and your business.

That’s why we have created this series of 13 short “Webisodes” focused on specific topics regarding the EU IVD Regulatory changes. With the length listed right next to it, you can choose what to watch based on your interest and the time you have.

Access the webisodes on the right hand column under “Additional Resources, Links.”

Note, you can watch the full 60-minute webinar recording, titled “Broader Regulatory Oversight of In Vitro Diagnostic Devices: A Deep Dive into the changes to the EU IVD Regulations” online.  Click here to go to the registration page.

These webisodes are led by:

Sue Spencer, Head of Global Medical Device Services at UL.

Sue Spencer has over 30 years’ experience in the IVD industry where she has held positions in R&D, Manufacturing and Quality Assurance; she has worked in the Notified Body arena since the initial introduction of the IVD and Medical Devices Directives and is now involved with the development of the new regulation.

Sue has over 10 years’ experience working for several Notified Bodies; she currently chairs the European IVD Notified Body Working Group coordinating the notified body responses to the changing regulatory environment. Sue also participates in the Commission IVD Technical Work Group and chairs a sub group preparing guidance on the revised IVD classification.

In the past Sue has worked as a consultant establishing her own consultancy before joining Abbott Diagnostics Division where she was Manager for International Quality Systems and Risk Management for the Division for over 6 years.

Sue is an experienced tutor on a variety of topics including the IVD Directive, ISO 13485 and risk management.

Within the UL family of companies we provide a broad portfolio of offerings to all the Medical Device industries.  This includes certification, notified body and consultancy services In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our Brand and our customers brands UL is unable to provide consultancy services to Notified Body or MDSAP customers.  UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality.