ISO 14971 – Fundamentals of Risk Management ———————————————————– Intended for: Quality Assurance, Designers, Regulatory Affairs Price: Please enquire. This course covers: – Introduction to Risk Management activities – Hazard Analysis – pFMEA, dFMEA, uFMEA – Risk/Benefit Statements – Contents...

ISO 13485:2016 – Introduction and Fundamentals ———————————————————– Audience: Introductory, Quality Assurance, Design and Production Price: Please enquire. This course covers: – Introduction to Quality Management Systems (QMS) – Introduction to ISO 13485:2016 – Fundamental requirements of ISO...

Internal Auditing for Medical Devices ———————————————————– Intended for: Quality Assurance, Internal Auditors Price: Please enquire. This course covers: – Basic of auditing – Auditing Techniques – Audit trail generation – Writing comprehensive audit reports – Follow-up of audit results...