2020 EU In Vitro Diagnostic Regulation Workshop
The IVD industry is undergoing significant change. Join BSI experts at our In Vitro Diagnostic Regulation Workshop where you can learn about some of the most significant changes to the European Regulatory and Compliance requirements for CE marking.

Please click below to register for your chosen location.
Register here
Early Bird rate now available until February 28th!
Enter the promotional code 'IVDR2020EarlyBird' when booking to get a 20% discount (Full price £249 incl. VAT).

For any questions please call us at +31 (0)615 226 550, or
email eu.medicaldevices@bsigroup.com.

 

Expect the most detailed insights

 

Engage with the only notified body with two full scope designations to the IVDR


BSI hosts its second EU In Vitro Diagnostic Regulation (IVDR) Workshop for the in vitro diagnostic device manufacturer, regulatory affairs, quality assurance and related consulting community.

Our unique EU IVDR Workshop event is exclusively focused on addressing the European IVDR.

BSI will be sharing our current experiences, best practice and expectations from the perspective of the leading global medical device Notified Body, ISO 13485 registrar, MDSAP Auditing Organization and the world’s first national standards body.

Learn more about the IVDR here.

 

Topics and Schedule


8:00 am – 8:30 am Networking Breakfast
8:30 am – 8:45 am
Welcome and Introduction
8:45 am – 9:15 am


Initial Lessons Learned from an IVDR designated NB
9:15 am – 10:15 am



Product Classification, Grouping and Conformity Assessment Routes with Workshop – Part I
10:15 am – 10:30 am Coffee Break
10:30 am – 11:00 am



Product Classification, Grouping and Conformity Assessment Routes with Workshop – Part II
11:00 am – 12:00 pm




QMS Requirements, Technical Documentation Requirements and Performance Evaluation with Workshop – Part I
12:00 pm – 1:00 pm Lunch
1:00 pm – 1:30 pm




QMS Requirements, Technical Documentation Requirements and Performance Evaluation with Workshop – Part II
1:30 pm – 2:00 pm


What we know about Companion Diagnostics under the IVDR
2:00 pm – 2:30 pm

Post Market Expectations, from a NB perspective
2:30 pm – 3:00 pm

What we look for with Labeling and UDI
3:00 pm – 3:15 pm Coffee Break
3:15 pm – 3:45 pm


Preparing a Successful IVDR Application with Workshop
3:45 pm – 4:30 pm



Using the remaining transition time efficiently; why you should not delay in approaching an NB!
4:30 pm – 5:00 pm Wrap up and questions

The advantage of an industry-leading Medical Device team

Our Global Medical Device team is composed of more than 140 technical experts and over 200 Auditors in medical technology with a combined 3,000 years of regulatory, industry and academic experience. Your presenters for this conference include:


Erica Conway, Global Head of the IVD Team

Erica has responsibility for CE Marking and ISO 13485 activities for clients worldwide. Before joining BSI, Erica held roles including QA/RA Manager, Regulatory Affairs Consultant and Project Manager within the IVD and pharmacology industries. This gave Erica experience in design and development, clinical chemistry, immunology, medicinal product development and companion diagnostics, among other areas. Erica also has expertise in the regulatory requirements of clinical chemistry. Erica is experienced in the implementation and maintenance of ISO 13485. Erica holds a BSc (Hons) in Physiology from the University of Sheffield, and a PhD in Neurophysiology from the University of Bristol.

Elizabeth (Liz) Harrison, IVD Technical Team Manager

Liz has responsibility for CE Marking and ISO 13485 activities for clients worldwide. Before joining BSI, Liz held senior and principle scientist roles in design and development of NAT/NGS 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 from UMIST, Manchester and a PhD in molecular diagnostics from the University of Bath.

Carlos Galamba, IVD Technical Team Manager

Carlos leads a group of IVD technical specialists who provide CE marking recommendations to the Notified Body. Carlos joined BSI in 2015 from the UK National Health System (NHS) where he held senior scientist roles in the field of clinical haematology, blood transfusion and transplantation, working with some of the highest risk class IVDs. He holds a BSc in Biomedical Sciences, a specialisation in transfusion practice and a MSc in International Management of Health Systems.

Heike Möhlig-Zuttermeister, IVD Technical Team Manager

Heike has responsibility for CE Marking and ISO 13485 activities for clients worldwide. Before joining BSI, Heike was Head of Research & Development within the IVD and life science industries. This gave Heike experience in regulatory requirements for a broad product portfolio in immunology, infectious diseases, clinical chemistry and cancer, among other areas. Heike is experienced in the implementation and maintenance of 98/79/EC and ISO 13485. Heike holds a PhD in Molecular Immunology from the University of Kiel, Germany.

Sabina Patel, IVD Technical Specialist/Scheme Manager

Sabina has responsibility for CE marking and ISO 13485 activities for clients worldwide. As a molecular biologist with over 10 years’ experience in diagnostic development, clinical trial implementation and commercialisation, Sabina has made significant contributions to the world of companion and cancer diagnostics. Sabina has extensive experience in the development and implementation of diagnostic regulatory strategy. During her time at QIAGEN, Sabina was involved in the development of one of the world’s first companion diagnostic kits for KRAS and EGFR mutation detection. Whilst at AstraZeneca, Sabina was involved in the approval of Tagrisso and lead efforts in plasma ctDNA test implementation. Sabina holds a BSc (Hons) in Biomedical Sciences from the University of Sheffield and PhD in Molecular Biology from the University of Liverpool.

Your Support Extends to the Entire BSI IVD Team

With experience in all risk-class device profiles, including established and novel technologies, our team can offer your organization, from new venture to complex multi-national, the total solution to navigate the regulatory pathways and demonstrate robust compliance. The BSI IVD team consists of 17 technical experts, with an average of over 17 years' IVD industry and regulatory experience. The team has a combination of clinical and regulatory expertise, providing for the full scope of the IVDR. Our areas of expertise range from blood grouping and tissue typing to oncology, genetic testing, infectious disease, and physiological markers, and cover the full range of specialized devices, including companion diagnostics, near patient tests and self-tests.

Dates, locations, addresses
and contact information for the event venues

March 03, 2020 – London

Book now

Sheraton Skyline Hotel London
Bath Road (A4)
Hayes, Middlesex
UB3 5BP
United Kingdom

+44 20 8759 2535
Hotel website

March 10, 2020 – Munich

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Eden Hotel Wolff
Arnulfstraße 4
D-80335 München
Germany

+49 (0)89 55 11 5-0
Hotel website

March 25, 2020 – Amsterdam

Book now

Mercure Hotel Amsterdam City
Joan Muyskenweg 10
1096 CJ Amsterdam
The Netherlands

+31 (0)20 721 9176
Hotel website

The BSI Medical Devices mission:
To ensure patient safety while supporting timely access to advanced medical device technology

We strive to set the global standard in thorough, responsive, robust conformity assessments, evaluations, and certifications.

BSI equips businesses with the necessary solutions to turn standards of best practice into habits of excellence. From assessment, certification and training to software solutions, advisory services and supply chain intelligence*, BSI provides the full solution to facilitate business improvement and helps clients drive performance, manage risk and grow sustainably.

For organizations large and small, BSI enables resilience by embedding excellence to create relevant, safer and more secure products/services leveraging the passion and expertise of our people. Renowned for its marks of excellence, BSI’s influence spans across multiple sectors with a particular focus on Aerospace, Automotive, Built Environment, Food, Retail, Healthcare and IT.

* Due to BSI Group’s role as a designated EU Notified Body, no BSI Group company may provide any form of consultancy that could be in breach of the In Vitro Diagnostics Regulation. No BSI Group company may provide consultancy services to medical device manufacturers, commercial competitors or suppliers to the manufacturers. Consultancy clients are unable to take certification services from BSI Group within three years of the completion of the consultancy.