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    Showing 1-10 of 166 results

    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

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

    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

    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

    Technical Documentation for the Medical Device Regulation (MDR) Training Course

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

    Training & Qualifications

    EN 60601 Medical Electrical Equipment and Systems

    Explore EN 60601 standards for medical electrical equipment and systems, and BSI Group's expertise in ensuring compliance.

    Standards

    Implementation of the In Vitro Diagnostic Device Regulation for CE Marking Training Course

    Explore the role of risk management during product development and in post market follow up. Develop an understanding of the...

    Training & Qualifications

    Introduction to Medical Device Software Training Course

    Gain an understanding of the medical device software lifecycle processes, classification rules and development activities to meet regulatory requirements. This course...

    Training & Qualifications

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    IEC 61326-1:2020 E2E Coming Soon Standard
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