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Ashleigh

BIVDA Regulatory Affairs Spring Seminar took place on 8 March Membership NewsMembership News ArchiveRegulatory Affairs Working PartyRegulatory Affairs Working Party Archive

BIVDA Regulatory Affairs Spring Seminar took place on 8 March

The Seminar covered the following topics: MHRA Software Roadmap with Johan Ordish (MHRA) MHRA IVD Roadmap, UKCA, and the Life Science Review with Ashleigh Batchen (BIVDA), Tom Beale (Agilent Technologies) and Camilla Fleetcroft MDCG Roadmap with Andrew Rutter (QuidelOrtho) Class D IVDs with Erica Conway (MCRA) BSI Standards with Rob Turpin (BSI) US Regulatory Process Stuart Angell (IVDeology) The event…
Natalie Creaney
March 17, 2023
BIVDA’s Head of Reg Affairs to speak at MedTech Conference – sign-up now! Membership NewsMembership News Archive

BIVDA’s Head of Reg Affairs to speak at MedTech Conference – sign-up now!

Ashleigh Batchen, BIVDA’s Head of Regulatory Affairs is to speak at Element’s MedTech Conference in March alongside other esteemed guests, such as Professor Michael Lewis, Life Science and Innovation, University of Birmingham and Joint Director, NIHR and Lewis Oakley, Innovation Lead - Heath Technologies, Innovate UK. Element's MedTech Conference seeks to challenge the existing regulatory structures and discuss how medical…
Ben Kemp
January 27, 2023
Regulatory Affairs Manager Ashleigh to present at ‘IVD School’ Membership NewsMembership News Archive

Regulatory Affairs Manager Ashleigh to present at ‘IVD School’

BIVDA’s Regulatory Affairs Manager, Ashleigh Batchen, will be a keynote speaker at ‘The IVD School’, which will run from 28-30th March. The training course, part of the MedTech Series, will navigate through the entire in vitro diagnostic lifecycle in 3 days of sessions: from introductions to all stakeholders in the in vitro diagnostic ecosystem, regulatory pathways for diagnostic approval and…
Natalie Creaney
January 20, 2023
Ashleigh speaks at the MedTech Summit 2022 Membership NewsMembership News Archive

Ashleigh speaks at the MedTech Summit 2022

Thursday was filled with many of the same messages that we have been hearing from our membership: the date of application of IVDR may have come and gone, but the work does not stop in becoming IVDR compliant, and there remains a shortage of IVDR Notified Bodies. This is a consensus shared across the sector, including from industry, the European…
Natalie Creaney
June 24, 2022