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Upcoming Events Regulatory Affairs Newsletter Archive

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QARAD: What’s the latest in the field of In Vitro Diagnostics?

Be ready to tackle the challenges of clinical performance studies under the IVDR 5 December 2024 | 16:00 CET Are you in full preparation for a new IVD submission or looking to refine your current approach? Then our upcoming webinar ‘Mastering Clinical Performance Studies under IVDR’ will provide actionable guidance to help you succeed. Our IVD experts will delve into…
Ben Kemp
December 4, 2024
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Assess Your Organisation’s Cybersecurity Maturity

You are invited to participate in MDIC’s Medical Device Cybersecurity Maturity Industry Benchmarking Assessment designed to help medical device manufacturers further examine their cybersecurity posture and address potential risks across the total product life cycle. Your participation provides critical insights into the current state of cybersecurity maturity in the medical device industry. By participating, your organization will receive a confidential…
Ben Kemp
November 14, 2024
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The Role of AI in the Practice of Human Factors Engineering

Wednesday, Nov, 20, 2024 | 9:00 AM - 10:00 AM CST Join subject matter experts, Michael Wiklund, Principal consultant, and Julee Henry, Lead human factors specialist from Emergo by UL’s Human Factors Research & Design team on Nov. 20th, 2024 from 9:00 – 10:00 AM CST for an insightful session on the role of AI in the practice of human…
Ben Kemp
November 14, 2024
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Successful Regulatory Strategy: Best Practices for the Diagnostic Sector

Our 2025 Regulatory Affairs Seminar is bringing together expert speakers to show how to develop a successful regulatory strategy; from bringing products to the market to navigating post-market surveillance. With confirmed speakers from BSI, MedTech Europe, TUV Sud, and the MHRA, the two-day event on 11th and 12th February 2025 is one not to be missed by regulatory specialists. BIVDA's…
Ben Kemp
November 13, 2024
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Online course: TOPRA IVD Regulatory Affairs for Global Markets

TOPRA’s Regulatory Affairs for Global Markets course takes place on 19-20 November and will be co-chaired by BIVDA’s Chair of the Regulatory Affairs Working Party, Stuart Angell, and BIVDA alumni, Ashleigh Batchen, now of TUV SUD. This two-day CRED course will cover the latest updates in globalmarkets including the US, Canada, China and Brazil and will also address key areas…
Ben Kemp
November 5, 2024
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BSI Meet the Experts: In Vitro Diagnostics Regulation event – BIVDA Member 25% Discount

The BSI Meet the Experts: In Vitro Diagnostics Regulation event is taking place in Amsterdam on 27 November 2024. BIVDA members can get a 25% discount for the event. Make sure to use the code MTENLBIVDA at checkout. BIVDA members can register for the event here. This IVDR focussed event has been designed for regulatory professionals, specialists and consultants from…
Ben Kemp
October 22, 2024
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Prepare for ISO 42001 webinar

There's still time to register for our upcoming webinar: Prepare for ISO 42001 – a framework for the management of AI. In this session we will discuss how organizations can proactively prepare for upcoming AI regulations by implementing the right processes and controls. This webinar is ideally suited for professionals across a wide range of industries that are looking to…
Ben Kemp
October 16, 2024
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Stay Compliant with New IVD Regulations

Wednesday, Oct,16th , 2024 | 9:00 AM – 9:45 AM (Austin Texas, U.S.) Join Heather Crawford from the Emergo by UL’s team, live on Oct. 16, 2024 from 9-9:45 a.m. CST as she discusses Regulation (EU) 2024/1860. What has changed with the adoption of Regulation (EU) 2024/1860, and how can you determine whether you are eligible for the extension under…
Ben Kemp
October 15, 2024
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EPO free online event

Patents and innovation in European universities The IPO UK has contributed to a European Patent Office (EPO) “Patents and innovation in European universities” study. On the 22 October the EPO’s Observatory on Patents and Technology will be hosting an online event on technology transfer and academic innovation in Europe, to mark its first anniversary. This event brings together key stakeholders…
Ben Kemp
October 15, 2024
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