Training of Internal Auditors in Relation to MDR
Gain practical knowledge of the MDR requirements that extend beyond ISO 13485 and understand how these requirements impact your Quality Management System (QMS).
Training Overview
This training provides medical device professionals with a practical understanding of auditing Quality Management Systems (QMS) against the requirements of the EU Medical Device Regulation (MDR).
Participants will explore where MDR expands beyond ISO 13485 and how those additional regulatory requirements influence quality systems, internal audit programs, supplier oversight, and overall compliance activities.
- Date: October 26, 2026
- Time: 9:00 AM to 5:00 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)
Valentina Lintas
Quality and Regulatory Affairs Manager
Valentina is a biomedical engineer with over seven years of experience in the medical device industry, specializing in regulatory and quality affairs. She holds a strong academic and research background in tissue engineering and minimally invasive cardiovascular technologies, which she has successfully translated into regulatory expertise across diverse MedTech domains. At Veranex, Valentina contributes to a wide range of regulatory and quality activities, including the drafting and critical review of technical documentation, development of regulatory strategies for EU, CH, and US markets, execution of QMS audits, and tailored support for quality system implementation and compliance with European medical device regulations.
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Training Objectives
Participants will develop the ability to:
- Understand the MDR requirements that are not addressed within ISO 13485.
- Interpret MDR requirements related to Quality Management Systems and their practical impact.
- Identify what auditors should evaluate when auditing a QMS for MDR compliance.
- Strengthen internal audit planning and execution for regulatory compliance.
- Improve organizational readiness for notified body and regulatory inspections.
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Training Content
- Risk Management
- Unique Device Identifier (UDI) & EUDAMED
- Person Responsible for Regulatory Compliance (PRRC)
- Liability requirements
- Registration of economic operators and obligations of:
- EU Representatives
- Importers
- Distributors
- Regulatory compliance requirements and conformity assessment
- Post-Market Surveillance (PMS)
- Vigilance requirements
- Clinical Investigation and Clinical Evaluation processes
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Training Format
- Expert-led presentations
- Interactive discussions
- Individual and group exercises
- End-of-training assessment
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Prerequisite
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None
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Target Audience
- Quality Managers
- Professionals responsible for implementing MDR requirements into the Quality Management System
- Internal Auditors
- Supplier Auditors
- Regulatory Affairs professionals supporting MDR compliance
- Quality professionals responsible for maintaining MDR conformity
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Price
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Member price: 5,810 DKK ex. VAT (~$845 USD ex. VAT)
- 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.