BIVDA updates Regulatory Affairs Newsletter – Page 3

BIVDA updates Regulatory Affairs Newsletter BIVDA Updates Regulatory Affairs Newsletter Archive Regulatory Affairs Newsletter Regulatory Affairs Newsletter Archive

BIVDA’s new Regulatory email

BIVDA has recently established a new email address dedicated to handling all regulatory enquiries. If you have any questions, concerns, or require assistance regarding regulatory matters or any events, we kindly ask you to contact our Regulatory Affairs email (Regulatory@bivda.org.uk). This will then be managed by either Ashleigh or Tehelj. If you are awaiting a response to any questions sent…

adminMay 19, 2023

BIVDA Updates Environmental Newsletter BIVDA Updates Environmental Newsletter Archive BIVDA updates Regulatory Affairs Newsletter BIVDA Updates Regulatory Affairs Newsletter Archive MedTech Europe Updates Environmental Newsletter MedTech Europe Updates Environmental Newsletter Archive MedTech Europe Updates Regulatory Affairs Newsletter MedTech Europe Updates Regulatory Affairs Newsletter Archive

Request for information on labelling

There is work ongoing within MedTech Europe on labelling of medical devices. To support in this work, MedTech Europe have requested the following information from industry by 28 April. Data on financial impact of additional labelling requirements arising from any jurisdiction. Costs of label development/production per major jurisdiction are welcome (e.g. to prepare a specific label for certain region/country; percentage of…

adminApril 21, 2023

BIVDA updates Regulatory Affairs Newsletter Membership News Membership News Archive Upcoming Events Regulatory Affairs Newsletter

TOPRA training discount for BIVDA members

TOPRA, The Organisation for Professionals in Regulatory Affairs, host a variety of training in the regulatory space that may be beneficial to BIVDA members. To encourage continued development of regulatory knowledge, we are partnering with TOPRA to offer a discount for BIVDA member organisations. A number of courses are planned this year, with a number involving BIVDA engagement: Regulation of…

adminApril 6, 2023

BIVDA updates Regulatory Affairs Newsletter BIVDA Updates Regulatory Affairs Newsletter Archive

CPD certificate available for BIVDA Spring Regulatory Seminar

If you attended the BIVDA Spring Regulatory Seminar on 8 March, you are eligible for a CPD certificate. If you would like to receive a certificate for your CPD log, please contact Natalie to request one (natalie@bivda.org.uk).

adminApril 3, 2023

BIVDA Updates Environmental Newsletter Archive BIVDA updates Regulatory Affairs Newsletter

BIVDA Spring Regulatory Affairs 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…

adminMarch 24, 2023

BIVDA Updates Environmental Newsletter BIVDA updates Regulatory Affairs Newsletter European Commission Updates Environmental Newsletter FDA updates Regulatory Affairs Newsletter Funding/Grant Opportunities Regulatory Affairs Newsletter MedTech Europe Updates Environmental Newsletter Other Updates Environmental Newsletter Other Updates Regulatory Affairs Newsletter Upcoming Events Regulatory Affairs Newsletter

Welcome to BIVDA’s new newsletter!

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adminMarch 9, 2023