Training: MDSAP Fundamentals and Readiness Training
Build the knowledge and practical confidence to understand MDSAP audit expectations, prepare your quality system, and host audits with greater readiness.
Training Overview
MDSAP audits require more than general quality system awareness.
Teams need to understand how the Medical Device Single Audit Program is structured, how audit processes connect, what documentation is expected, and how jurisdictional requirements affect readiness.
This two-day training helps participants increase their knowledge of MDSAP regulatory audit guidelines and the skills needed to determine whether their organization is prepared to host an audit. The course focuses on MDSAP fundamentals, audit process requirements, reporting, nonconformity grading, documentation, and readiness planning.
- Date: June 3 to June 4, 2026
- Time: 9:00 AM to 5:00 PM CET
- Price:
Member price: 12,900 DKK ex. VAT (~$2,019 USD ex. VAT)
Non-member price: 19,840 DKK ex. VAT (~$3,105 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
Participants will learn how to:
- Demonstrate awareness of MDSAP fundamentals
- Explain the structure and scope of the MDSAP audit program
- Understand MDSAP audit processes and their interrelationships
- Connect MDSAP requirements to organizational regulatory compliance
- Understand MDSAP reporting and nonconformity grading
- Explain differences between MDSAP and other QMS audits
- Understand MDSAP auditing in the medical device industry
- Connect MDSAP readiness to ISO 13485 and ISO 14971
- Identify MDSAP documentation expectations
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Training Content
Participants will learn how to prepare for successfully hosting a MDSAP audit, including:
- MDSAP seven auditing process requirements
- Audit scope planning
- Data sources required during process audits
- Control interaction analysis
- Correct jurisdictional terminology
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Training Format
Online with:
- Presentations with interactive discussions
- Group and individual exercises
- End-of-training assessment
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Prerequisite
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.
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Price
Member: 12,900 DKK ex. VAT (~$2,019 USD ex. VAT)
Non-member: 19,840 DKK ex. VAT (~$3,105 USD ex. VAT)
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.