Course details

Who should attend?

Regulatory, quality, design (including design changes), development, manufacturing, marketing managers and personnel
Decision makers on management system strategy
Internal auditors
What will I learn?

On completion of this training, participants will be able to:
Identify the links between ISO 13485 (Quality Managment for Medical Devices) and ISO 14971 (Risk Management)
Explain how risk management relates to the product lifecycle
Define risk management terminology
Outline the stages of the risk management process
Define the key deliverables of the risk management process
What are the benefits?

You will gain an understanding of the impact that ISO 14971:2009 has on the decision making process when manufacturing medical devices.
What is included?

Training course notes
Lunch
Refreshments

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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