Stefan Klein
Mdr Site Auditor, Mdr Product Reviewer at Qmd Services
Based in Munich, Germany
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Seniority
Other
Department
Other
Location
Munich
Industry
Medical Device
Company size
25
Contact information
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s•••••••@qmdservices.com
Phone
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Background
About Stefan Klein
25 years experience in Quality & Regulatory Management Systems (ISO 13485/9001/21CFR820) of medical device industry. Development and implementation of Quality and Regulatory Management Strategy. Implementation and certification of multi site Quality Management System according to ISO 13485, MDSAP and FDA requirements. Specialties: MDD, IVD, MDR, IVDR, 21CFR820, MDSAP, ISO 13485, 510(k), ISO 14971 (Risk Management), Quality Management System, Internal Audits,ISO 19011, Supplier Audits, ISO 14001, EMAS, REACH, China RoHS, Compliance Management System, Regulatory Affairs.
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