Medical Device Quality Management (ISO 13485, etc.)
Remote Training
The remote training courses listed below cover knowledge and skills related to:
- Implementing and maintaining ISO 13485 quality management systems for medical devices.
- Auditing ISO 13485 quality management systems.
- Applying ISO 14971 requirements for risk management of medical devices.
- MDSAP (Medical Device Single Audit Program)
Choose the module that fits your needs, or combine modules to establish a combined knowledge competency.
COMBINED TRAINING! – ISO 13485:2016 Internal Auditor
Combine training modules to gain the knowledge competency that qualifies you as an ISO 13485:2016 Internal Auditor.
Understanding ISO 13485:2016 Requirements
(2 sessions of 4 hours each)
Internal Audits
(2 sessions of 3.5 hours each)
Understanding ISO 13485:2016 Requirements
A detailed review of the ISO 13485:2016 requirements for quality management systems.
2 separate sessions of 4 hours each.
(Combine with “Internal Auditing” module for competency as an internal auditor.)
Internal Auditing
The skills, techniques and guidance to conduct internal audits.
2 separate sessions of 3.5 hours each.
(Combine with any “Understanding” module for competency as an internal auditor.)
Understanding ISO 14971:2019 Requirements
Requirements and guidance on the application of risk management for medical devices.
2 separate sessions of 4 hours each.
MDSAP (Medical Device Single Audit Program)
Provides the knowledge and skills to successfully host an MDSAP audit within your organization. Content is based on the MDSAP G0002.1.0004 Companion Document and reviews the MDSAP processes with an emphasis on the associated audit tasks.
2 separate sessions of 4 hours each.
