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Erik J. van den Wijngaard is an experienced professional in quality management within the medical device sector, currently serving as the Owner of Informs Quality Consulting since January 2013, providing expertise in Lean Quality Management Systems (QMS) for startups. In addition to consulting, Erik holds the position of Quality Manager at Capri-Medical, where responsibilities include building a quality management system from the ground up. Previous roles include Director Quality at Sirius Medical Systems and Salvia BioElectronics, where Erik accomplished ISO 13485 certifications and developed technical files for CE marked products. Further experience includes Quality Consultant roles for various companies, including Corbion and Artinis Medical Systems. Erik has also contributed to various quality-focused initiatives at Philips in different capacities related to quality and regulatory processes. Educational qualifications span multiple degrees from Eindhoven University of Technology and Fontys Hogeschool Eindhoven.