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
Course Location
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- Vaccine and Vaccination The Teachers TrainingSGD 17
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