BSI Meet the Experts: IVDR key learnings 18 months after the DoA

We are happy to invite you to our in-person annual BSI Meet the Experts meeting in Amsterdam on 2 November 2023, fully dedicated to the EU IVDR. With the IVDR having entered into force on 26 May 2022, there are still many questions and challenges for IVD manufacturers facing the difficult task of implementing the regulation. 

Join this extended meeting to hear about the latest IVD regulatory updates, clarification on specific IVDR requirements and lessons learnt related to Performance Evaluation, QMS, Technical documentations submission, PMS and much more.

Don’t miss this unique opportunity to meet and connect  with our IVDR experts and with the commercial team to address your IVDR challenges and key questions.

The meeting will be preceded by a Get Together session on 1 November, 18:00-20:00 CET. All speakers will be present during the evening reception on 1 November so please join us. 

Agenda

Dates

• 1 November 2023: Get together session (18:00-20:00 CET)
• 2 November 2023: IVDR meeting (09:00-17:00 CET)

Event location

Mercure Hotel Amsterdam City, Joan Muyskenweg 10, Amsterdam – 1096CJ

See Google Map

Registration fees

€100 per person (incl. VAT)

Note: In case of cancellation the Eventbrite admin fee will still apply.

Alex Laan is BSI's Head of the Notified Body IVD. In this position, Alex will be focusing on further strengthening the regulatory foundations within the IVD team and make BSI future-proof for the years to come in the challenging regulatory environment in the EU for IVD’s. Alex is originally a biochemical engineer and worked on the design and development of ELISA based assays in virology and immunohematology tests. He has worked a technical specialist in reagents and tests at Sanquin blood bank located in Amsterdam. He holds degrees in Biomedical Chemistry, Biotechnology, and Business Administration.

Dr Elizabeth Harrison is BSI's Global Head of In Vitro Diagnostics. She is responsible for operational delivery of technical documentation review and certificate decisions for IVDD, IVDR and UKCA. Before joining BSI in 2014, she held senior and principle scientist roles in design and development of NAT diagnostic platforms for near-patient testing of sepsis, respiratory infections, genetic disease, cancer and companion diagnostics. She also spent time as a post-doctoral scientist in the School of Translational Medicine at the University of Manchester investigating rapid diagnostics for sepsis and respiratory disease. Liz holds a BSc (Hons) in Biochemistry and a PhD in molecular diagnostics.

Victoria Cox, IVD sales manager for EIMEA is responsible for the commercial team that support manufacturers in the application process for ISO 13485, MDSAP and IVDR. Victoria joined BSI in 2018 and moved to Regulatory Services in 2020 and has extensive knowledge of the IVD industry and Medical Devices industry. Prior to working at BSI she had worked with clients assisting them with governance, risk and compliance solutions to aid them to protect their organisations. 

Charlotte Hess has joined BSI in 2017. She’s is currently the Senior IVD
Business Development Manager for Northern Europe, managing IVDR
applications with BSI. Charlotte has solid knowledge of the IVD industry and understands the complexity of the IVDR applications. Whether you're starting the certification process, looking to transfer or just need to discuss options
for your business, Charlotte can guide you efficiently through the
process.

Dr Ana Chiva joined BSI in 2020 and is a Scheme Manager & Technical Specialist. In her role, she manages the IVDR, IVDD and UKCA certification of a client portfolio and performs technical reviews. She is also involved in internal training and mentoring. Before joining BSI, Ana worked as a Senior R&D Manager in design and development of haemostasis assays and genetic sequencing systems in the IVD industry. She also spent time as a post-doctoral researcher at University College London developing assays to detect early stages of cardiovascular disease. Ana holds a BSc (Hons) in Chemistry and a PhD in Biochemistry.

Dr Clemens Busse is currently working as a Senior Client Manager, Medical Devices at BSI, covering EMEA.  He has worked in the IVD industry since 2009 in responsible functions for design and development and quality control. His tasks involved research activities, project planning and budgeting, development planning, data evaluation, raw material validation, performance and stability studies, and product troubleshooting. The product range he was responsible for during his career covers manual assays to fully automated solutions. He obtained an engineering degree in Biotechnology and a PHD from the German Cancer Research Center in Heidelberg, Germany, in molecular virology.

James Kerr has been a Technical Specialist & Scheme Manager at BSI for three years working on IVDR, IVDD and UKCA conformity assessment and certificate recommendations. He joined BSI with ten years’ experience working for IVD manufacturers, holding positions in R&D and Manufacturing. His design experience includes laboratory and near-patient systems for cancer, hemostasis, cardiology, diabetes and immunodeficiency, primarily leveraging immunoassay and enzymatic technologies’

Seán O'Callaghan has recently joined BSI as a Technical Specialist & Scheme Manager. Prior to BSI he worked for the Irish Notified Body, NSAI, for 5 years. There he held multiple roles which included ISO 13485:2016 and Regulatory auditing and reviewing technical documentation under both the Directives and Regulations. He was the Regulatory Lead for NSAI's IVDR Regulation and Interim Head of the Notified Body. Prior to working for Notified Bodies Seán worked as a Biomedical Scientist across multiple laboratories in the fields of Histopatholoy, Haematology & Transfusion and BioChemistry. Seán holds a BSc in Biomedical Science and a post graduate Degree in Haematology and Transfusion. He has recently completed a MSc in International Regulatory Affairs for Medical Devices and Technologies.

Purvi Patel is a Regulatory Lead who works on CE schemes and the implementation of UKCA legislation at BSI. Purvi has an extensive background in conducting BSI technical reviews. Prior to joining BSI in 2017, Purvi has held various positions in the medical devices industry working at Zimmer Biomet, Renishaw plc, Surgicraft Ltd. and Finsbury Orthopaedics Ltd. Purvi holds a Master’s degree (Biomedical Engineering) and PhD (Screw Fixation of Implants to the Spine) from the University of Birmingham (UK) and has over 15 years of experience working with medical devices in academia, industry and the Notified/Approved Body.