Introduction to Risk Management for Medical Devices

This one-day training course helps medical device professionals gain an understanding of how ISO 14971 can improve their business and risk management efforts. Participants will also understand how ISO 14971 applies to ISO 13485. The training includes exercises, and participants will have the chance to ask questions about how ISO 14971 and risk management apply to their organizations. 


Who should attend?

  • Regulatory, quality, design (including design changes), development, manufacturing, marketing managers and personnel  
  • Decision makers on management system strategy
  • Internal auditors
“The delegates were given freedom to discuss their own experiences and the tutor related these experiences to the course.”

What will I learn?

On completion of this training, participants will be able to:  

  • Identify the links between ISO 13485 (QMS) and ISO 14971 (RM)
  • 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 

How will I benefit?

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

What's included?

  • Training course notes
  • Lunch
  • Refreshments

Mode of Payment

You can make payment through Cheque, NEFT transfer, e-payment or UPI payment.

Below are the details 

BSI Group India Private Limited 
Current Account No.: 166045294001
HSBC Bank, 25, Barakhamba Road, New Delhi-110 001
IFSC/RTGS Code: HSBC0110002
Swift Code: HSBCINBB
UPI Code: bsiindia@hsbc

Please note: Service tax will be charged extra as per prevailing Government rates.

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