MMD-122    ISO 13485:2016, Medical Device Single Audit Program (MDSAP),
                      Medical Device Regulation (MDR) Internal Auditor Training 
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  • Overview
  • Course Objectives
  • Course Content
  • For Whom
  • Schedule and Hours
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This course provides the participants with the knowledge and skills to conduct the internal audits of the QMS based on the relevant audit criteria like ISO 13485:2016, MDSAP, MDR. Participants will learn how to use risk-based approach in the internal audit and learn how to report on the effective implementation and maintenance of management system in accordance with ISO 19011. 

ISO 13485:2016, MDSAP, MDR specifies requirements for a quality management system for quality management system that can be used by an organization involved in one or more stages of the life-cycle of a medical device. To address the requirements of most of the regulatory requirements, manufacturers must demonstrate their commitment to the safety and performance of their medical devices. 

This course enables a clause by clause understanding of ISO 13485:2016, MDSAP, MDR which provides an effective solution to make effective QMS.   
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The training provides:
  • To Develop your knowledge of how the requirements of respective standard like ISO 13485:2016, MDSAP, MDR are fulfilled and help the organization to fulfil the regulatory requirements.
  • Give participants an awareness of ISO13485 and its alignment to respective Quality System Regulation
  • Assist participants in the relationship between QMS and registration
  • Identify what ISO13485 and also what is regulatory expectation
  • Understand the guidelines of QMS auditing accordance to ISO 19011:2018 and internal audit process from initiating, preparing, conducting audit activities, preparing and distributing the audit report
  • Understand the application of the risk-based approach in medical device QMS and implement during the internal audit
  • To handle the non-conformance effectively and help the client understand the clause of ISO 13485:2016, MDSAP, MDR requirements
  • Module 1: Introduction to Auditing
  • Module 2: The Process Approach and Process Auditing
  • Module 3: Managing Audit Program        
  • Module 4: Practical Internal Audit    
  • Module 5: Non-conformity Management
This course is designed for individuals involved in the auditing, maintaining and monitoring of QMS against ISO 13485:2016, MDSAP, MDR.
This is a 2-days programme.
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This course runs from 9:00am – 5:00pm with an hour for lunch and periodic short breaks.
 
This is an intensive session designed to include as much discussion as possible. Lunch and breaks provide an opportunity for further questioning and discussion with the instructors.

We are HRD Corp (Human Resource Development Corporation) Registered Training Provider.
​All of our training modules are claimable under HRD Corp.