![]() Development and Design File requirements for Medical Devices.This course covers the following GMP/ISO 13485 QMS requirements: ![]() Medical device QMS requirements training course (overview) Suppliers including material suppliers, facility contractors, and equipment maintenance companies.Medical Device personnel must be trained in this standard, including:.It is also a standard referred to by Auditing Organisations (AOs) participating in the IMDRF MDSAP program (Medical Device Single Audit Program).It is a standard that a majority of Regulatory Authorities will refer to during inspections and audits of medical device manufacturing sites and distribution processes.ISO 13485:2016 is an internationally accepted standard covering Quality Management Systems (QMS) requirements for Medical Device companies.What is the ISO 13485:2016 QMS standard for Medical Device Manufacturers? Recommended follow-up training: ISO 14971 (Quality Risk Management requirements. Medical Device QMS Standards: GMP training materialsĪ convenient multi-media online GMP course to help quality managers, Regulatory Authorities, Auditors, and operations personnel understand ISO 13485 standards for medical device Quality Management Systems (QMSs). ISO 13485:2016 QMS requirements: Medical Device Industry Education ( GMP Training Materials).
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