Highly specialized training courses

This on-demand intensive course is designed to increase your understanding of ISO 14971:2019 impact on decision-making in medical devices manufacturing processes.

It helps medical device professionals understand how ISO 14971:2019 can improve their business and risk management efforts.

This one-day intensive course increases your understanding on the impact that ISO 14971:2019 has on decision-making processes in medical devices manufacturing. The course is intended to provide key principles on risk management and ISO 14971 interaction with QSM standards and European Regulations (MDR/IVDR).

This course focuses on the clinical evaluation process including key requirements, principles, development stages, documentation, and related post-market activities. The course includes interactive activities to test your knowledge on clinical evaluation.

This one-day intensive course enables greater understanding of key requirements for manufacturing process validation for medical devices, as detailed in the European Medical Device Regulation (MDR) and ISO 13485:2016 requirements. The aim of the course is to increase your knowledge on evidence needed for manufacturing processes validation.

Increase knowledge and skills required to successfully host a Medical Device Single Audit Program (MDSAP) within your organization. Gain in depth knowledge on MDSAP structure, scope, and key differences from ISO 13485 audits.