An NSF International Company Medical Devices Auditor Academy
PrintNSF certified course
2499.99 Exc VAT (5 Days)
About this course
Medical device auditing is a specialist skill requiring a high degree of technical/process knowledge and a thorough understanding of medical device legislation, product and process specific standards, process validation, good manufacturing practices and risk management. This 5 day course is the first to combine all these aspects and provide you with the technical grounding to undertake assessments of your organisational internal processes, the supply chain and third party audits.
The course introduces the IMDRF (International Medical Device Regulators Forum) requirements for regulatory auditing as well as the US FDA Quality System inspection strategies and combines requirements within the medical device regulations (93/42/EEC, 90/385EEC and 98/79EEC, ISO 14971, ISO14155, post market surveillance and vigilance) as well as enabling you to interpret the requirements of the major regulatory GMP requirements (ISO13485:2003, CFR21 Part 820, Ordinance 169 and the CMDCAS requirement guidance in GD210). It takes you through the medical device regulations, principles of design, validation and risk management, as well as introducing you to some of the most common features of Third Party auditing in medical device organisations.
The course is fast paced, heavily workshop driven, intense and thorough, as it is used as a basis of demonstrating that you have achieved the necessary competence to lead audit teams and make key decisions associated with medical device regulation (Third Party approval, supply chain approval or
due diligence assessment)
This is a unique course brought to you by the most respected notified body auditors in the world. It is designed to address the fundamental failure of similar courses to provide third party auditors with the confidence to make regulatory decisions relating to medical device organisations.
