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. Register Now Please click above to register for your chosen location. Hotel information is located below.
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:
Rula Melconian, IVD Technical Specialist and Scheme Manager
Rula has thirty years' experience of management responsibility in the medical device industry in Quality Systems, Quality Assessments, Regulatory Affairs, Operations, Manufacturing Support, Project Management, and Design Transfer including roles as Client Manager and Lead Assessor. Rula has collaborated globally with the internal regulatory staff to develop harmonized policies, procedures and work instructions for emerging regulatory topics. She has facilitated the recall and adverse event subcommittee responsible for corporate decision on issuing recalls and adverse events to applicable regulatory agencies, and has worked with global regulators at USFDA, CMDCAS, ANVISA and EU Competent Authorities.
Stefan Burde, IVD Technical Specialist and Scheme Manager
Stefan has served as Technical Documentation Reviewer for products regulated under the European IVD Directive 98/79/EC, Quality Systems Assessor for ISO 13485:2016, CMDCAS, MDSAP, and as an instructor for courses on European IVD regulations. Previous to working with BSI, Stefan served as Staff Scientist and Section Head for BioMerieux, a major global diagnostics firm that sells a full range of in vitro diagnostic systems, as a Research Scientist for Bayer Biological Products and as a Post Doc and Technical Staff Member at Los Alamos National Laboratory.
Todd Moorman, VP, IVD Sales Solutions Americas
As the VP, IVD Sales Solutions Americas for BSI Regulatory Services (Medical Devices), Todd has a broad range of responsibilities focused on helping medical device manufacturers achieve quality systems registration and product certification. Mr. Moorman creates learning and development opportunities for clients and colleagues to gain knowledge of global regulatory requirements, medical technologies and the healthcare marketplace. Prior to his 13 years with BSI, Todd spent eleven years at Thomson Scientific, a division of the Thomson Reuters, where he led a team of product specialists, sales support, and customer trainers within the pharmaceutical/chemical sector. Todd earned his BA from the University of Kansas.
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.