Introduction to ISO 13485 Medical Devices BSI Singapore
Price: 450 SGD

    Course details

    Who should attend?

    Senior Management
    Quality Managers
    Regulatory Affairs Managers
    Internal and external Auditors
    Anyone involved with the implementation of the standard
    "The speaker was able to articulate the points very well and he also give good examples to allow us to understand better." Jo Ang, Becton Dickinson Medical
    What will I learn?

    On completion of this training, participants will be able to:
    Compare the requirements between ISO 13485 and ISO 9001
    Interpret the clauses of ISO 13485 using ISO 14969
    Recognize the role and responsibilities of management in ISO 13485
    Recognize the relationship between ISO 13485 and ISO 14971
    Compare the requirements between ISO 13485 and FDA's Quality System Regulation
    Appreciate the use of ISO 13485 as the basis of Medical Device Regulations worldwide.
    What are the benefits?

    Take the first steps towards ISO 13485 certification
    Understand how you can better meet customer and regulatory requirements
    Find ways to increase efficiency and cost savings through quality management
    Monitor supply chains to achieve continuous improvement
    Develop safe and effective medical devices
    What is included?

    Training course notes
    Lunch
    Refreshments
    Certificate of attendance

    Updated on 08 November, 2015

    About BSI Singapore

    BSI is the business standards company that helps organisations all over the world make excellence a habit. For more than a century BSI have been challenging mediocrity and complacency to help embed excellence into the way people and products work. That means showing businesses how to improve performance, reduce risk and achieve sustainable growth. As a global leader in helping organisations improve, BSI's clients range from high profile brands to small, local companies in 150 countries worldwide. See all BSI Singapore courses
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