Home > E-Learning> Understanding ISO 13485:2016
COST:$550
This e-Learning course fully covers the ISO 13485:2016 requirements. ISO 13485 specifies requirements for quality management systems in order to achieve regulatory compliance in the medical device sector. Many medical device companies are utilizing ISO 13485 as a platform to build their business management systems because of its value or because third party certification is a specified requirement by customers and/or regulators.
This class also covers the comparable 21 CFR 820 content for additional guidance for organizations in the Medical Device sector.
This e-Learning course is designed for Quality Assurance Practitioners, Managers, ISO 13485:2016 Implementation Team Members and Management Representatives.
A general understanding of quality management systems and a minimum of 3 months of relevant experience is recommended.
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