Training of internal auditors in relation to country specific requirements within the MDSAP program
The specific national requirements of the participating jurisdictions will be addressed with examples sampled over the subsystems.
Introduction
MDSAP is an auditing approach integrating the applicable requirements of the participating jurisdictions into an audit under ISO 13485. ISO 13485 requires compliance to applicable regulatory requirements of the target markets and the MDSAP defines the framework of the applicable requirements that must be covered by the manufacturers’ quality systems for the MDSAP jurisdictions.
Course objective and outcome
The course discusses the MDSAP audit approach that is focused on the logical links and flow of information. Further, we will discuss the logic of the audit to follow according to the MDSAP Companion chapters throughout the different subsystems. The specific national requirements of the participating jurisdictions (Ord.169, 21CFR820, RDC 16/2013, SOR 98-282, TGA MDR 2002) will be addresses and compared using examples sampled over the subsystems.
Attendees of the course will
- Understand the MDSAP policies and audit approach
- Know where to locate information
- Discuss and interpret MDSAP subjects related to ISO 13485 requirements
- Discuss evidence expected for fulfilling some of the specific requirements of participating jurisdictions
Content
- The Medical Device Single Audit Program, policies, coverage
- MDSAP Audit approach
- Prepare for hosting a MDSAP audit
- Overview of MDSAP Companion Chapters and links within Subsystems
- Auditing management system subsystems
- Auditing coverage of specific requirements of MDSAP jurisdictions and comparison of Ord.169, 21CFR820, RDC 16/2013, SOR 98-282, TGA MDR 2002 with referenced ISO 13485 clauses.
Who should attend
Quality system and Regulatory professionals with audit experience (trained internal auditors / experience to be exposed to FDA inspections or Notified Body Audits)
Trainer
Cedric Razaname, Veranex
What previous participants said
Contact
Select date
5.10.20265 October 2026 - at 09:00 - 16:00
Price ex. VATLatest Registration
28.09.2026
Latest Cancellation
14.09.2026
View Program
Terms
Related courses
ISO 13485 & Quality Management/Internal Auditing
IRCA Certified ISO 13485:2016 QMS Lead Auditor Training for Medical Devices
The New US Quality Management System Regulation QMSR and other US Regulations for Medical Devices
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Berit Munkebo
Head of Development
bm@medicoindustrien.dk
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