Training of Internal Auditors for MDSAP Country-Specific Requirements
Go beyond ISO 13485 and gain the practical knowledge needed to audit and prepare quality systems for the regulatory expectations of all five MDSAP participating jurisdictions.
Training Overview
This one-day online course provides experienced medical device quality and regulatory professionals with a practical understanding of the Medical Device Single Audit Program (MDSAP) and how country-specific regulatory requirements integrate into ISO 13485 quality systems.
- Date: October 5, 2026
- Time: 9:00 AM to 16:00 PM CET
- Price:
Member price: 5,810 DKK ex. VAT (~$845 USD ex. VAT)
Non-member price: 8,930 DKK ex. VAT (~$1,360 USD ex. VAT)
Cedric Razaname
Director, Quality and Regulatory Affairs - Head of QMS
Cédric holds a master’s degree in Microengineering from EPFL Lausanne. He has previously worked in various companies in the field of manufacturing engineering and products development. Cédric is an expert in Quality and Regulatory Affairs for medical devices and IVDs, with over 8+ years of experience implementing quality management systems and managing regulatory submissions. He has experience working in heavy constraint environments, particularly in ISO 13485 QMS and ISO 27001 ISMS deployment, IEC 62304 software lifecycle management and cybersecurity support. Cédric speaks fluently English, French and has a good understanding of German.
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Training Objectives
By the end of this course, you will be able to:
- Explain the MDSAP audit model and the logical flow of an audit
- Navigate and apply MDSAP Companion Documents during audit preparation
- Interpret country-specific regulatory requirements alongside ISO 13485
- Recognize the objective evidence auditors expect to see
- Strengthen internal audit planning and execution across multiple markets
- Identify common compliance gaps before an external audit
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Training Content
- Introduction to the Medical Device Single Audit Program (MDSAP)
- Understanding the MDSAP audit process and audit sequence
- Information flow across quality system subsystems
- Country-specific requirements for:
- United States
- Canada
- Brazil
- Australia
- Japan
- Comparing regulatory requirements with ISO 13485
- Review of MDSAP Companion Documents
- Practical examples and discussion of audit evidence
- Interactive exercises and knowledge assessment
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Training Format
- Live instructor-led presentations
- Interactive discussions and Q&A
- Individual and group exercises
- Practical audit examples
- End-of-training assessment
- Opportunities to discuss real-world MDSAP challenges
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Prerequisite
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None
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Target Audience
This course is designed for medical device industry professionals with responsibility for one or more elements of an organization’s quality management system, including staff and top management in regulatory compliance, QA/QC, and internal auditing such as:
- Quality Assurance Managers
- Internal Auditors
- Regulatory Affairs Professionals
- QA/QC Specialists
- Quality Engineers
- Compliance Managers
- Management Representatives
- Medical Device Manufacturers preparing for MDSAP audits
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Price
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Member price: 5,810 DKK ex. VAT (~$845 USD ex. VAT)
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Non-member price: 8,930 DKK ex. VAT (~$1,360 USD ex. VAT)
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Learn from Specialists Who Work Inside Medtech Complexity Every Day
Talk with Veranex about upcoming training dates, private sessions, or tailored programs built around your organization’s device, IVD, regulatory, clinical, or quality needs.