MDSAP implementers foundation course

A two-day course covering the Medical Device Single Audit Program (MDSAP) and its impact on auditing and monitoring the manufacturing of medical devices.

This course is designed to provide attendees with a detailed understanding of the Medical Device Single Audit Program. The program allows recognized auditing organizations to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.

The course will cover an overview of the MDSAP and how to use the MDSAP audit model and its tools.

Objective

  • On completion of this course, attendees will have gained an understanding of:
  • The requirements of the MDSAP;
  • The benefits of enrolling into the MDSAP program;

Pre-requisites

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

It is also recommended to have prior knowledge of the regulatory registration with the following countries and organizations:

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

Audience

This course is suitable for anyone seeking information on the MDSAP and includes:

  • Quality managers;
  • Regulatory affairs personnel;
  • Internal auditors.


All our public courses can also be delivered in-house at your premises either as standard or tailored depending on the needs and requirements of your business.

To find out which training courses we offer in your country, click on "Find a local course", select your country and navigate to Medical devices; or Contact us if you are interested or want to know more on in-house courses.

This course is designed to provide attendees with a detailed understanding of the Medical Device Single Audit Program. The program allows recognized auditing organizations to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.

The course will cover an overview of the MDSAP and how to use the MDSAP audit model and its tools.

Objective

  • On completion of this course, attendees will have gained an understanding of:
  • The requirements of the MDSAP;
  • The benefits of enrolling into the MDSAP program;

Pre-requisites

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

It is also recommended to have prior knowledge of the regulatory registration with the following countries and organizations:

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

Audience

This course is suitable for anyone seeking information on the MDSAP and includes:

  • Quality managers;
  • Regulatory affairs personnel;
  • Internal auditors.


All our public courses can also be delivered in-house at your premises either as standard or tailored depending on the needs and requirements of your business.

To find out which training courses we offer in your country, click on "Find a local course", select your country and navigate to Medical devices; or Contact us if you are interested or want to know more on in-house courses.