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ISO 13485 Certified Quality Manager - Medical Devices
Medical Devices
ISO 13485 Certified Quality Manager - Medical Devices

A 44-hour training program covering 5 e-courses: ISO 13485 Lead Auditor, ISO 14971 Risk Management, FDA 21 CFR Part 820 QMSR, GDP, and FMEA.

TR-QMS-CERT44 HoursAdvanced
ISO 14971:2019 Risk Management for Medical Devices
Medical Devices
ISO 14971:2019 Risk Management for Medical Devices

Understand the role of risk management in medical devices, practice fundamentals, and interpret ISO 14971 clauses.

TR-RM-012 Days (14 hrs)Intermediate
U.S. FDA 21 CFR Part 820 QMSR Requirements
Medical Devices
U.S. FDA 21 CFR Part 820 QMSR Requirements

Teaches the FDA Quality Management System Regulations (QMSR) required for Medical Devices with a Certificate of Competence.

TR-REG-032 Days (14 hrs)Intermediate
ISO 13485:2016 Lead Auditor Training Course
Medical Devices
ISO 13485:2016 Lead Auditor Training Course

Detailed understanding of ISO 13485 QMS requirements and ISO 19011 Lead Auditing principles with Exemplar Global certification.

TR-QMS-012 Days (14 hrs)Advanced
Good Documentation Practice (GDP) & Data Integrity
Medical Devices
Good Documentation Practice (GDP) & Data Integrity

Overview of key concepts and major requirements for ISO Good Documentation Practice and Data Integrity (ALCOA).

TR-QMS-GDP4 HoursBeginner
European Medical Device Regulation (EU) 2017/745 - MDR
Medical Devices
European Medical Device Regulation (EU) 2017/745 - MDR

Covers significant impacts on QMS, technical requirements, and responsibilities for manufacturers, importers, and distributors.

TR-EU-011 Day (7 hrs)Intermediate
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