Medical Device & IVD Experts
Specialists in Medical Devices & IVDs
Our team has vast experience in the medical device arena so we fully understand the intricacies of exporting to Europe and the regulatory responsibilities that come along with doing so.
Highly Organized and Process Oriented
Our goal is to fit seamlessly into the background of your distribution process. We don't take physical control of your products or interact with your customers. Our job is to ensure the smooth flow of your devices from your loading dock to your customers in Europe. To achieve that we have to be highly organized, holding ourselves to the same standards as the clients we serve. That's why MedEnvoy is currently implementing ISO 13485:2016.
The MedEnvoy Team
Meet us at one of these upcoming events.
Pepijn is Account Manager at MedEnvoy. He has a background in history, political cultures and national identities. He joined MedEnvoy in the spring of 2021 as the first official fulltime hire. His primary function is to guide clients during the onboarding process, and to manage the flow of data regarding shipments entering the European market.
Coen ten Cate
Coen is Account Managers at MedEnvoy. He joined MedEnvoy in September of 2021. He has a background in military and global history. As an account manager he guides clients during the onboarding process, and to manage the flow of data regarding shipments entering the European market.
Melle is Account Manager at MedEnvoy Global. Having studied Political Science (BSc) and History (MA), and having fulfilled several extracurricular activities, Melle has a sharp, analytical eye for detail as well as as a personal, clear style of communication. Melle will be guiding clients during the onboarding process, and managing dataflow procedures regarding EU-bound shipments.
Partner & Managing Director
In 2005 Edgar founded and managed the Distribution Division of Emergo till 2017 when it was spun out into Luctor Medical. With the introduction of the European Union’s MDR and IVDR, Edgar started to develop a new service "Independent Importer" and founded MedEnvoy Global in 2020 as a sister company of Luctor Medical. He has a long background in foreign direct investment, logistics and distribution.
Dr. Jaap Laufer
Partner & Director MedEnvoy
Switzerland & PRRC
Over his 35-year career in the Pharmaceutical and Medical Devices industry, Jaap has acquired a vast experience in the regulatory and clinical areas, mostly in Europe and the US. Jaap is a standing Member of the MDCG Working Group for Classification, and has been teaching at the University of Southern California (USC) in Los Angeles International Regulatory Affairs since 2006.
Business Manager UK
With 30 years’ experience in Medical Devices, the last 15 of which have been in International markets, Julian has significant experience in this arena and an extensive network of Worldwide contacts. Julian is the Business Manager UK for Medenvoy and looks after our new business in the UK. Living close to Manchester in the UK, Julian is involved in motor-racing and extreme sports.
Rachael is an Account Manager at MedEnvoy. She is from Austin, Texas & recently moved to the Netherlands. She joined MedEnvoy in the fall of 2021, where her primary function is the Switzerland market, helping to guide clients through the Swiss authorized representative process & Swiss importation process.
Alexandra has joined MedEnvoy as an Account Manager in November 2021. She is originally from Romania, but has also lived in both Switzerland and the Netherlands. Her international background aids in assisting clients during onboarding, while her precision is noticeable in the management of dataflow procedures concerning European shipments.
Dr. Stefan Tuschen
Partner & Operations Director
As a former physician and Partner with Boston Consulting Group (BCG) in Cologne, Germany, Stefan brings with him a thorough understanding of the entire healthcare environment. Among many other things he was responsible for coordinating the EU MDR related activities of BCG and has extensive commercialization experience in the EU, US and Russia/CIS markets.
René Van De Zande
Partner & Commercial Director
René is co-founder of Luctor Medical and MedEnvoy. He has notable achievements as an entrepreneur and executive. He founded Emergo in 1997 and under his leadership turned it into the leading global medtech regulatory affairs firm with offices in 25 countries. Emergo was acquired by Underwriters Laboratories (UL) in late 2017 and René continued as Managing Director through the end of 2019. He has a deep understanding of European regulatory issues.
Director Quality Assurance & Regulatory Affairs
Daryl has more than 25 years of experience in the medical device industry and has been specialized in Quality Management System (QMS) implementation and compliance, and regulatory submissions for medical devices. He has reviewed Health Canada submissions, FDA submissions, and Technical Files for medical device manufacturers around the world.