Search results, standards, training and certification

Creating and Maintaining Technical Files and Design Dossiers

This one day course is designed to support manufacturers by confirming current regulatory requirements of technical documentation.

Training & Qualifications

Medical Device Post Market Surveillance and Vigilance

BSI’s ‘Post-market Surveillance and Vigilance under the Medical Device Regulation (MDR) and In Vitro Diagnostics Medical Devices Regulation (IVDR)’ one-day...

Training & Qualifications

Medical Device Post Market Surveillance and Vigilance

Post-market surveillance including clinical follow-up, complaint and vigilance handling, impacts on all aspects of the quality management system.

Training & Qualifications

Corso Combinations Medicinal Products and Medical Devices – ART 117

This course involves practical activities, group discussions and classroom learning to help you develop a deeper understanding of the material...

Training & Qualifications

Performance evaluation and clinical evidence for In Vitro Diagnostics (IVDs)

If you are involved in planning, conducting or documenting performance evaluation and clinical performance studies for IVD devices in Europe,...

Training & Qualifications

Sustainable Palm Oil Is Good for the Planet, People and Protected Species

Bringing environmental sustainability and social responsibility to the palm oil production supply chain. RSPO certification.

System Certification

Manufacturing Process Validation for Medical Devices: Introduction to Concepts and Methods

This one-day intensive course enables greater understanding of the key requirements for manufacturing process validation for medical devices, in line...

Training & Qualifications