Introduction to ISO 13485:2016 Medical Devices

This one day course has been designed to provide an insight into the use of ISO 13485:2016 as the basis for a quality management system implemented by medical device manufacturers.

Time will be spent during the course exploring the requirements of ISO 13485:2016 and how the standard interacts with ISO 9001:2015, the European Medical Device Directive and the US FDA’s Quality System Regulation. In addition to this, participants will also gain an awareness of the relationship between ISO 13485:2016 and ISO 14971, Application of Risk Management to Medical Devices.

Who should attend?

  • Senior Management
  • Quality Managers
  • Regulatory Affairs Managers
  • Internal and external Auditors
  • Consultants
  • Anyone involved with the implementation of the standard
"Our international reach is unrivalled with operations in 147 countries"

What will I learn?

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

  • Use ISO 13485:2016 as the basis for a QMS for medical device manufacturers
  • Understand the relationship between ISO 13485:2016 and European Medical Device Directives
  • Use ISO 13485:2016 as the basis of regulatory requirements worldwide.

How will I benefit?

  • Take the first steps towards ISO 13485:2016 certification
  • Understand how you can better meet customer and regulatory requirements leading to increased patient safety
  • Find ways to increase efficiency and cost savings through quality management
  • Monitor supply chains to achieve continuous improvement
  • Develop safe and effective medical devices
  • Motivate employees through CPD.

What's included?

  • Training course notes
  • Lunch
  • Refreshments
  • Loan copy of the standard (to be returned after the course)

     

  • Suitable for small groups
  • Suitable for single person
  • Learn from other organizations
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  • Suitable for large groups
  • Flexible & convenient
  • Tailored for your needs
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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

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Please note: GST (Goods & Service tax) will be charged extra as per prevailing Government rates.