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IVDD RECAST and impact on IVD instrumentation manufacturers

During this presentation we will drive you through the basic needs that IVD manufacturers are expected to fulfill by the legislator in Europe. Furthermore we will drive you through the impact an IVD instrumentation manufacturer might encounter in the coming years, according to the changes the European commission is planning in the so-called RECAST IVD Directive. Next to the change in technical regulatory requirements, the fundamental change planned is passing from a regulation to a law, with all consequences related, like e.g the missing translation into national law.

 

Dr. Prisca Zammaretti, Head Regulatory Affairs RDI - Roche Diagnostics Ltd.

Dr. Prisca Zammaretti has spent several years in food, Pharma and medical devices market. She started in the R&D area and developed over the years a specific interest for medical devices and their regulations. During the last 5 years she led the regulatory affairs department at Roche Diagnostics International Ldt in Rotkreuz, Switzerland. In this function she could navigate around the different aspects of IVD regulations worldwide, from lab automation to software or analyzers of different sorts.

Francesca Cipolli, Regulatory Affairs Manager - Roche Diagnostics Ltd.

Francesca Cipolli has spent several years in food, Pharma , medical devices and IVDs market. She has begun her career in quality management and moved to international regulatory affairs for medical devices 6 years ago. She currently works at Roche Diagnostics International Ldt as Global Regulatory Affairs Manager, with specific focus on LAS and Standalone Software used in Health Care environment.

 

 

 

 

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