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Format: Live Virtual/ Face-to-Face

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Learning Objectives:

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• ​​Dive deep into the nuances of ISO 13485: 2016 standard.

• Understand the purpose of a medical device quality management system.

• Interaction with appropriate medical device regulatory authority requirements, quality management systems standards, third-party certification.

• The business benefits of the quality management system.

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Course Outline:

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• This course covers majorly:

  • Introduction to ISO 13485:2016

  • Quality management system

  • Management responsibility

  • Resource management

  • Product realization

  • Measurement, analysis and improvement

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• Highly interactive and practical learning with case studies & group activities

• Post test to assess the attendees’ learning at the end of the course

• Issuance of training completion certificate to attendees (with Shaarkview and Customer’s management signatures).

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• At the end of the course, students can be able to have a decent understanding on requirements of ISO 13485”2016. 

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Who Should Attend:​

• All stakeholders involve in implementation of and compliance to ISO 13485:2016.

• QA, QC, Production, Engineering, Warehouse & Others.

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Course Duration:  8 hours 

 

Training Days: 

• Live Virtual program: (One of the following options)

  • 1- Saturday / 1- Sunday, 09.00 to 18.00 Hr 

  • 1- Weekday (Mon/Tue/Wed/Thu/Fri), 09.00 to 18.00 Hr  

  • 2- Weekdays (Mon/Tue/Wed/Thu/Fri), 18.00 to 22.00 Hr 

• Face-to-Face program:​

  • 1- Weekday (Mon/Tue/Wed/Thu/Fri), 09.00 to 18.00 Hr 

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Language of Instruction: English​

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​​Instructor: Seetharam Kandarpa

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For Organization specific training class / other queries: 

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