Medical Devices Regulatory Training ISO 13485

Design and develop medical devices to international quality standards, ensure smooth submission, meet ISO 13485 standards, satisfy customers and keep ahead of all regulatory developments with our medical devices training courses.

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 organisation, our technical support and expertise can get you ahead of the game. Choose from our range of courses that can be delivered online, on-site or through a public programme. We can also tailor a course that meets your specific training needs, helping you to overcome challenges and make sure your medical devices are more than fit for purpose.




Awareness Training

Device – Drug Combinations: Practical Guidance on Borderline Issues and the Consultation Process

£800 + VAT

1 day classroom based training course

    • Reduce risk, avoid mistakes and speed up compliance with EU Medical Device Directive (MDD) regulations
    • If you work with ancillary medical substances or derivatives of human blood or plasma, we can help you remove all uncertainty from the consultation process
View details for Device – Drug Combinations: Practical Guidance on Borderline Issues and the Consultation Process

An introduction to the Saudi Food and Drug Authority (SFDA) new mandatory Medical Device Interim Regulations (MDIR) and the online application process

£820 + VAT

1 day classroom based training course

    • Attend BSI’s ‘introduction to the SFDA new mandatory MDIR and the online application process’ one day course and start making informed decisions with regard to meeting the requirements of the SFDA
    • Identify potential commercial impact to your business
View details for An introduction to the Saudi Food and Drug Authority (SFDA) new mandatory Medical Device Interim Regulations (MDIR) and the online application process

Implementation Training


Auditor training


Specialist Training