Transition process IVDD to IVDR

Beni Hirt is CEO of Decomplix - a compliance partner and CH-REP that simplifies market access in Switzerland. Beni builds and maintains customer relationships with Medtech companies of all shapes and sizes - from start-ups to corporates - in Switzerland and all around the world. He helps them overcome regulatory hurdles and shorten the time to market. Beni is an entrepreneur with experience in founding and leading new companies pioneering in the digital environment. He was co-founder and CEO of one of the most successful Swiss app agencies.
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Heike Idink is a Regulatory Affairs & Quality Management professional with more than 20 years of experience in regulated fields like Medical Devices, Biotechnology and pharmaceuticals. Heike Idink holds a PhD of Natural Sciences from the RWTH Aachen, Germany, and a Master of Business Law from FFHS, Switzerland. With her extensive regulatory expertise, she supports Decomplix clients in particular with questions relating to in-vitro diagnostics and due diligence assessments.
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Helena Lacalle is a Regulatory Affairs professional with over 20 years of experience in strictly regulated fields like medical devices and pharmaceuticals. Helena Lacalle holds a pharmacist degree from the University of Barcelona, a Master degree in Statistics from the University of Neuchatel, Switzerland, and has strong language skills in English, French, and Spanish. With her extensive regulatory expertise, she supports Decomplix’ customers both on strategic levels and on detailed regulatory questions.
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Jessica M. Ruperto is a regulatory affairs expert with over 13 years of experience across multiple industries, including medical devices, in-vitro diagnostics (IVDs), and tobacco. Jessica holds a BS in Industrial Microbiology and a Juris Doctorate, along with a Regulatory Affairs Certificate from the Regulatory Affairs Professionals Society (RAPS). She has also completed ISO 13485:2016 Auditor Training and HIPAA Privacy & Security Training for Business Associates. Jessica's extensive expertise includes compiling and maintaining regulatory submissions, identifying regulatory requirements for new and existing products, and ensuring compliance with global regulations. She has a strong track record in contributing to new product development, reviewing product labeling and marketing materials, and providing regulatory guidance to cross-functional teams.