Quality Management Systems and QMS Assessments expert
Albert Koster, MSc
After having 10 years of medical device industry practice, he joined Qserve as a consultant in a range of quality and regulatory projects. From CE technical files, 510(k)’s, to development of Quality systems, interim Quality Assurance (QA) / Regulatory Affairs (RA) management.
Now as of June 2017 he has decided to join Qserve again as Senior Consultant in order to assist manufacturers in these demanding times to comply with medical device regulations.
Prior to Qserve, he worked at BSI as Client Manager and Lead auditor for medical device manufacturers and is qualified for ISO 9001, ISO 13485, CMDCAS, MDD for a large range of qualification codes. In this capacity, he has audited many companies across the EMEA region and subsequently gained very strong Auditing skills. In his last year within BSI he completed also a range of ISO 13485:2016 transition audits and has been fully trained for the new Medical Device Single Audit Program (MDSAP).
Albert holds a Bachelor and Master of Science degree in mechanical engineering and product design. He has started his career at Nucletron, now Elekta in The Netherlands, manufacturer of radiotherapy equipment, as a design engineer and development project manager with both non-active applicators and interfaces to active equipment. After that, he worked as consultant in product design, where he gained more hands-on experience with CAD-CAM design, CNC processing, injection molding and programming. However, returned quickly to the medical device industry to develop again radiotherapy equipment by joining a small startup company Isodose Control (now also Elekta).
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