Medical device regulatory training

CE marking training

• Medical Device Directive (MDD) to Medical Device Regulation (MDR)
• IVD Directive (IVDD) to IVD Regulation (IVDR) Transition
• Requirements of the Medical Device Regulation (MDR) for CE Marking
• Requirements of the In Vitro Diagnostic Regulation (IVDR) for CE Marking
• Implementation of the Medical Device Regulation (MDR) for CE Marking
• Implementation of the In Vitro Diagnostic Device Regulation (IVDR) for CE Marking
• Medical Devices CE Marking

ISO 13485 training

• ISO 13485:2016 Senior Management Briefing
• Introduction to ISO 13485:2016
• Implementing ISO 13485:2016
• ISO 13485:2016 Internal Auditor (TPECS)
• ISO 13485:2016 Lead Auditor (TPECS)
• ISO 13485:2016 Requirements (TPECS)
• Transition Course from 13485:2003 to 13485:2016
• ISO 13485:2016 Auditor Refresher
• ISO 13485:2016 Transition

Specialist training

• Medical Device Single Audit Program Fundamentals and Readiness Training Course
• Medical Devices Risk Management: ISO 14971
• Understanding ISO 14971:2007
• Performance Evaluation (P/E) and Clinical Evidence for IVDs
• Clinical Evaluation for Medical Devices
• Medicinal Products and Medical Devices Combinations: Requirements of the MDR Article 117

Artificial Intelligence for medical devices training 

• How to assess robustness of neural networks awareness on-demand training course
• Robustness for neural networks – ISO/IEC 24029-1:2021 introduction on-demand training course

When you’re working with BSI, you’re working with an organization that operates throughout the world of standards. We offer one of the widest ranges of standards-related training available from meeting medical devices regulation to managing your energy effectively. We don’t just train you to meet standards – we helped to shape and develop many of them and we carry out the audits and assessments.

When you train with us, you get the full benefit of that 360-degree expert knowledge. We know what an audit will look for – so we train you to meet it. We know the thinking behind the standard – so we can convey that to drive and inspire your people.

We have a team of expert course owners working across the world who can transfer the knowledge, skills and tools your people need to embed standards of excellence into your organization. They have vast amounts of training and assessment experience, and work across a wide range of business sectors.

They know best how to transform your organization by training those who can make that change – that’s how we turn our experience into your expertise.

Quality management is crucial to success in the competitive and complicated medical devices marketplace. And our trainers have the practical experience to understand the regulatory challenges you face. We can help you to put in place successful ISO 13485 compliant quality and medical devices management systems.

Regardless of the size or location of your organization, our technical support and expertise can get you ahead of the game. Choose from our range of courses that can be delivered online or through a public training program.