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 (Spring 2022)

"A very knowledgeable teacher giving examples from his
previous experience. The teacher has been working with NBs so he has been "sitting on the other side of the table"

"Really liked the information on specific requirements on a difficult subject"

"Good course material, good instructor"

"Instructor was very knowledgable"