Keynote Address from TÜV SÜD and Amgen at Medical Devices and IVD Conference in November

SMi Group reports: Navigating new legislations and strategies to comply with regulatory requirements.

London, United Kingdom, July 21, 2021 --( The MDR and IVDR updates will have a profound impact on the medical device industry, bringing certain products into regulatory scope that were previously excluded, introducing new manufacturing requirements, and increasing the burden for post-market surveillance. What does this mean for the future of the Medical Devices and IVD industry?

More information on the programme and speaker line-up can be found here:

IVDR implementation: State of play, the Notified Body view
• Status of IVDR implementation: Where do we see the bottlenecks.
• Lessons learnt from IVDR certification projects
• What should manufacturers consider during the remaining time until DoA
Andreas Stange, Vice President, TÜV SÜD

Combination Products: End-to-End Risk Management
• Product Development and Lifecycle Management are founded on principles of risk management
• Key considerations for Risk Management for Combination Products
Susan Neadle, Executive Director, Combination Products, Devices, Diagnostics & Digital Health Regulatory Affairs, Amgen

Benefit of Attending:
• Engage with notified body and competent authority representatives addressing key MDR and IVDR requirements
• Gain insights from pharma regulatory experts in compliance and companion diagnostics
• Understand the latest guidance on Post-Brexit IVD Regulations to overcome common challenges, in addition to considering evolving global regulations
• Examine post-market expectations for surveillance and vigilance of your medical devices
• Delve into how COVID-19 has impacted the MDR and IVD regulations

Register online by 30th September and save £100:

About SMi Group:
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