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BIVDA updates Regulatory Affairs NewsletterBIVDA Updates Regulatory Affairs Newsletter ArchiveMembership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

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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Section 524B: Navigating Healthcare Cybersecurity Compliance – Webinar

The intersection of healthcare and cybersecurity has become a critical bridge in safeguarding patient data and ensuring the integrity of medical technologies. Unpack the complexities of Section 524B, a key legislative directive aimed at fortifying cybersecurity measures within the healthcare sector. You’ll gain insights, get strategic advice, and learn practical steps for complying with Section 524B for medical software development…
Ben Kemp
October 9, 2024
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UK and Ireland Association of Forensic Toxicologists Conference, 10-11th October 2024

I would like to draw your attention to the upcoming UK and Ireland Association of Forensic Toxicologists (UKIAFT) meeting on 10-11th October at Voco Hotel, Leicester (agenda attached). UKIAFT has an annual meeting focussing on post-mortem / forensic toxicology (http://www.ukiaft.co.uk/). Registration includes a tour of the Leicester Tigers stadium (adjacent to Voco) with drinks and canapes followed by the conference meal with…
Ben Kemp
October 1, 2024
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“Understanding IVDR Clinical Evidence Requirements”

Join this free webinar to get invaluable insights on how to understand the Clinical Evidence IVDR life cycle concept to ensure continuous safety and performance of state-of-the-art IVDs. Sebastian Grömminger Principal Consultant at Entourage and I will explore how to master the Clinical Evidence IVDR life cycle concept to ensure continuous supply of safe and state of the art IVDs.…
Ben Kemp
October 1, 2024