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.

Designed to increase your understanding of performance evaluation and clinical evidence for In Vitro Diagnostic medical devices and their interaction with product development lifecycle and IVDR requirements.

This one-day training course has been designed to increase manufacturers’ knowledge on the requirements to comply with to implement an appropriate post-market surveillance and vigilance system under MDR and IVDR.

This one-day intensive course increases your understanding on key requirements for technical documentation for IVDs, in accordance with IVDR requirements.

This one-day intensive course increases your understanding on key requirements for technical documentation for medical devices, in accordance with MDR.

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.