ISO 13485:2016 AWARENESS TRAINING

COURSE SCHEDULE

Course Objectives

• Get introduced to MDSAP, management and measurement

• Understand the analysis and improvement

• Understand the design, development and production

• Understand the service controls, purchasing

• Understand the device marketing authorization and facility registration

Course Duration

2 days

Course outline

The MDSAP Training program shall cover the following modules:

• Introduction to MDSAP, management and measurement

• Analysis and improvement

• Design and development and production

• Service controls, purchasing

• Device marketing authorization and facility registration

• Medical device adverse events and advisory notices

• Country specific requirements - USA, Brazil, Australia, Canada and Japan

Who Should Attend?

• Quality Assurance and Regulatory Affairs professionals within medical device organizations currently active in participating territories and organizations expanding their market reach to jurisdictions participating in MDSAP.

Pre-requisites

• Delegates will benefit from reviewing the MDSAP Companion Document and ISO 13485:2016 standard before attending this course.

Examination & Certification

• An attendance certificate would be provided to the participants on successful completion of the training program