MDSAP - MEDICAL DEVICE SINGLE AUDIT PROGRAM

FOUNDATION TRAINING

About MDSAP - MEDICAL DEVICE SINGLE AUDIT PROGRAM

Why this course:

This course pack is designed to give you a detailed understanding of the medical device single audit program. After the training you will have a good knowledge of the MDSAP regulatory requirements, skills to implement the requirements within your organisation and an increased readiness to host a MDSAP audit.

Who can attend this course:

  • Quality Managers
  • Regulatory Affairs personnel 
  • Internal Auditors

Pre-requisites:

For successful completion of this course, it is expected that you have prior knowledge of ISO 13485:2016 standard. 

It is also recommended to have prior knowledge of the Regulatory Registration with the following countries:

  • FDA – US
  • ANVISA – Brazil
  • HC – Canada
  • TGA – Australia
  • PMDA – Japan

Language:

The training is in English.

Course highlights:

  • An overview of the MDSAP
  • Focus on key Processes 
  • How to use the MDSAP Audit Model and its tools

Course objectives:

At the end of this training session, you will have a very good understanding of:

  • The requirements as stated in the MDSAP and 
  • The benefits of enrolling into the MDSAP Program

Venue:

The training is held as online training.

About MDSAP - MEDICAL DEVICE SINGLE AUDIT PROGRAM

Why this course:

This course pack is designed to give you a detailed understanding of the medical device single audit program. After the training you will have a good knowledge of the MDSAP regulatory requirements, skills to implement the requirements within your organisation and an increased readiness to host a MDSAP audit.

Who can attend this course:

  • Quality Managers
  • Regulatory Affairs personnel 
  • Internal Auditors

Pre-requisites:

For successful completion of this course, it is expected that you have prior knowledge of ISO 13485:2016 standard. 

It is also recommended to have prior knowledge of the Regulatory Registration with the following countries:

  • FDA – US
  • ANVISA – Brazil
  • HC – Canada
  • TGA – Australia
  • PMDA – Japan

Language:

The training is in English.

Course highlights:

  • An overview of the MDSAP
  • Focus on key Processes 
  • How to use the MDSAP Audit Model and its tools

Course objectives:

At the end of this training session, you will have a very good understanding of:

  • The requirements as stated in the MDSAP and 
  • The benefits of enrolling into the MDSAP Program

Venue:

The training is held as online training.

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