ISO 13485 Series
Medical Device
Master ISO 13485 compliance and stay competitive with our Medical Device Trainings.
Stay ahead in the dynamic field of medical devices with APEX QA’s comprehensive training programs. Our courses are designed to equip professionals with the knowledge and skills needed to navigate complex regulatory landscapes and ensure compliance with ISO 13485 standards. From Internal Auditor training to Lead Auditor courses recognized by Exemplar Global, our offerings cover auditing processes, risk management, and the implementation of quality management systems.
Whether you’re looking to deepen your understanding of ISO 13485 requirements or seeking to streamline compliance with EU MDR regulations, our specialized training has you covered. With a focus on practical application and industry best practices, APEX QA empowers medical device professionals to excel in their roles and drive continuous improvement within their organizations.
Medical Device Training Courses
ISO 14971:2019 Risk Management for Medical Device – PFMEA Live-Online (2-Day)
$1,295.00Learn the application of the FMEA approach to ISO 14971:2019 Application of Risk Management to Medical Devices, and be able to define the use of DFMEAs as a process within your…
ISO 13485:2016 Internal Auditor Exemplar Global Recognized (3-Day)
$1,695.00Learn how to interpret the 13485 Standard and apply it to your own organization. This course prepares you to perform effective audits of Medical Device Quality Management Systems. Within…
ISO 13485:2016 Lead Auditor with 21 CFR820 Exemplar Global Recognized (5-Day)
$2,195.00This seminar fully covers the ISO 13485:2016 requirements. Auditing topics from ISO 19011 such as the auditing process and methodologies, e. g. planning and conducting an audit,…
ISO 13485:2016 Internal Auditor Live-Online (2-Day)
$1,295.00Medical device auditing requires technical knowledge as well as a deep understanding of international medical device regulations. Students participating in this course will gain knowledge…
MDSAP Training: Understanding the Requirements of ISO 13485:2016 & International MDSAP Audit Model (2-Day)
$1,295.00Understanding MDSAP training course will teach students to plan, develop and implement a QMS in accordance with MDSAP and ISO 13485:2016 requirements. Considering the ISO 13485:2016…
MDSAP Training: Internal Auditor Training Based on ISO 13485:2016 & International MDSAP Audit Model Exemplar Global Certified (4-Day)
$2,095.00Medical device auditing requires technical knowledge as well as a deep understanding of international medical device regulations. Students participating in this course will gain knowledge…
MDSAP Training: Lead Auditor Training Based on ISO 13485:2016 & International MDSAP Audit Model (5-Day)
$2,195.00Considering the ISO 13485:2016 management system requirements and various regulatory authorities compliance requirements around the world and the global supply chains involved, a…