2019 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 Expectations for CE marking. Apr 30, 2019 - San José, CAMay 07, 2019 - Boston, MAPlease click above to register for your chosen session location. Hotel information is located below.
Expect the most detailed IVD regulation insights
Correct IVDR Compliance = EU Market Access
BSI is proud to host our inaugural 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 world’s first national standards body.
Topics and Schedule
|8:30am – 8:45am||Welcome and Intro|
|8:45am – 10:00am
||IVDR Overview, Classification, Grouping Devices|
|10:00am – 10:15am||Coffee break|
|10:15am – 10:45am
||Interacting with the Notified Body|
|10:45am – 11:30pm
||Technical Documentation Requirements|
|11:30am – 12:00pm
||New Requirements for Performance Evaluation|
|1:00pm - 2:00pm||Post-launch Requirements|
|2:00pm – 2:15pm||Coffee break|
|2:15pm - 3:15pm
||Workshop: Using the Remaining Transition Period Effectively|
|3:15pm – 3:30 pm||Some Common Pitfalls|
|3:30pm – 4:00pm||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.
Rula Melconian, IVD Technical Specialist and Scheme Manager
Rula has thirty years of management responsibility in 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 with global regulators at USFDA, CAMDCAS, ANVISA and EU Competent Authorities.
Stefan Burde, IVD Technical Specialist
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 EU IVDD 98/79/EC schemes and 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.
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 9 technical experts, with an average of 16 years IVD industry and regulatory experience. The team has a combination of clinical and regulatory expertise, including companion diagnostics, infectious disease and cancer markers.