Jan van Lochem holds masters degrees in biomedical materials and business marketing. Starting his career in R&D on PTCA catheters, he entered the regulatory field as auditor and technical product specialist for cardiovascular devices at a European Notified Body in 1996. From 2000 to 2003 he worked in the United States to build a Notified Body presence. As Head of Notified Body and regulatory specialist in the European Medical Device Directives, he has been involved from early stages in European MRA’s with Canada, USA, Australia. He has implemented Third Party accreditations for various international regulatory programs such as Canadian CMDCAS, FDA 510(k) AP reviews, Taiwan and Australia CAB. Since 2000 he had global responsibility for KEMA Notified Body, focused their strategy on high innovative medtech devices in US, Europe, Japan, Israel and build it out to one of the larger Notified Bodies worldwide. He acquired and implemented 2 Notified Bodies. He has joined BSi in April 2009 as Vice President Healthcare, EMEA & AsiaPac to further strengthen BSi’s focus on the medtech sector in general and expand its presence in Europe and Asia. He is a frequent speaker on developments of European regulations for medical devices and heads the initiative of the 5 largest notified bodies to create a more even level playing field among Notified Bodies.
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