SMi Group reports: Navigating new legislations and strategies to comply with regulatory requirements
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:
www.medicaldevices-ivd.com/pjpr3
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: www.medicaldevices-ivd.com/pjpr3
#MedicalDevicesIVD
About SMi Group:
Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward-thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk