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.