BSI has been a leading Notified Body for Medical Devices in Europe for over 25 years. As we experience the "single largest change" in regulation for the Medical Devices industry, we invite you to join our live session with Jayanth Katta, Regulatory Lead at BSI for a Notified Body overview and the latest update on EU Medical Device Regulations.

Speaker:

Jayanth Katta, PhD
Regulatory Lead, BSI

Now that medical devices and in vitro diagnostic medical devices carry UDI regulatory requirements at a global scale, how will your organization respond to meet UDI data management around the globe? Regulatory UDI requirements started with the US, spread to the European Union, and are now emerging in South Korea, Saudi Arabia, China, and other regions. In parallel, your commercial business partners are starting to revise their contracts to specify UDI be placed on products and available electronically for published product catalogs.

This discussion will review current regional unique device identification initiatives, timelines, and expected future challenges in implementing UDI. Our featured speaker will also review the advantages of a central product information management solution that will better prepare you to make an informed decision in defining your unique device identification roadmap. Get an update on EU UDI and future global regulators.

Speaker:

Gary Saner
Sr. Manager, Information Solutions Life Sciences
Reed Tech

With the MDR enforcement deadline approaching fast, companies may have a plan in place to ensure data and documentation meet the requirements. But what happens after May 2020? How do companies move beyond the basics to create a strategy that meets MDR, modernizes systems for more efficiency and doesn’t put long-term strain on their organizations?

True success means transitioning the MDR programme to the business and redefining team responsibilities.

Join this webinar to find out how technology can support this transition and help businesses to:

• Set-up proactive reporting structure
• Identify source of data in minutes
• Move towards regulatory intelligence
• Improve team alignment across functions
• Enable compliance and audit readiness

Speaker:

Annemien Pullen
Director Strategy, Vault Medical Devices & Diagnostics
Veeva Systems

• Clarifying requirements for risk management, clinical evaluation and PMS under the MDR and understanding how they’re aligned
• Understanding how RM, CE and PMS Plans are aligned and correlated in different companies
• Examining the best way to consolidate available information
• Common pitfalls
• Advice for industry

Speaker:

Caroline Byrd
Director, Commercial RA/QA
Leica Biosystems

• Assessing key vigilance changes and requirements for combination products under the EU MDR
• Understanding how Competent Authority and Notified Body expectations have changed
• How should vigilance be reported? What’s new?
• Assessing requirements for borderline products
• Outlining common pitfalls and how they can be avoided

Speaker:

Dr. Fatima Sanfourche
Deputy Director, Medical Device Safety
Bayer

• Highlighting key differences between the previous and new regulations
• Undertaking a gap analysis to assess where resource should be dedicated
• Understanding and preparing for the new classification requirements
• Strategies for gaining senior management buy-in
• Discussion on identifying an selecting a Notified Body
• Common pitfalls and advice for industry

Speaker:

Richard Young
Acclaim Biomedical