Global Learning for Operational Leaders
Classroom
14 sessions
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Online / Live
14 sessions
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Introduction
Course overview
Medical device manufacturers must maintain quality management systems that meet ISO 13485 and regulatory requirements such as the EU Medical Device Regulation. Compliance is essential for market access and patient safety.
This Aractech course explains ISO 13485 requirements, risk management links, design and development controls, purchasing and supplier controls, production and process validation, complaint handling and vigilance, CAPA and regulatory interfaces. Participants assess gaps in a case quality system.
The course suits quality and regulatory professionals in the medical device sector.
What you will achieve
Learning objectives
- Explain ISO 13485 structure and requirements
- Apply design and development controls
- Manage suppliers and purchasing
- Validate production processes
- Handle complaints, vigilance and CAPA
- Prepare for audits and regulatory inspections
Who should attend
Target audience
- Medical device quality professionals
- Regulatory affairs staff
- Design engineers
- Production managers
- Auditors
- Suppliers to the medical device industry
Methodology
Learning approach
- Standard walkthroughs
- Case studies
- Gap assessment exercise
- Group discussions
- Documentation reviews
Complete course outline
Five focused days of learning and application
The timings provided are estimates and may vary depending on the number of participants and the discussions taking place during the sessions. They are indicative only and do not constitute a binding commitment.
Day 1
ISO 13485 Overview
- Medical device regulation context
- Structure of ISO 13485
- Differences from ISO 9001
- Documentation
- Coffee break
- Documentation (continued)
- Management responsibility
- Exercise: Gap assessment start
Day 2
Design and Risk
- Design and development controls
- Design reviews and verification
- Risk management links
- Coffee break
- Risk management links (continued)
- Usability
- Design transfer
- Workshop: Design control review
Day 3
Suppliers and Production
- Supplier controls
- Purchasing
- Process validation
- Sterilisation and cleanliness
- Coffee break
- Sterilisation and cleanliness (continued)
- Traceability
- Exercise: Process validation plan
Day 4
Post-Market Processes
- Complaint handling
- Vigilance reporting
- CAPA
- Recalls
- Coffee break
- Recalls (continued)
- Post-market surveillance
- Case study: Device complaint
Day 5
Audits and Improvement
- Internal audits
- Notified body audits
- Management review
- Coffee break
- Management review (continued)
- Continuous improvement
- Regulatory updates
- Capstone: Quality system gap report
FAQ
Frequently asked questions
What does Medical Device Quality Management (ISO 13485) (QP-022) cover?
This course covers Quality and Productivity through a structured five-day outline focused on practical application, discussion, and implementation planning.
When is the next available session?
The next scheduled session starts on 16 - 20 November 2026. See the course schedules section for the available dates and delivery formats.
Who should attend this course?
Medical device quality professionals, Regulatory affairs staff, Design engineers
Is bilingual course delivery available?
Yes. All course materials and presentations are provided in English, while bilingual explanation and discussion support may be available depending on the selected location and trainer availability. For example, when attending a course in Istanbul, you may request a Turkish-speaking trainer to explain the English course content in Turkish. Arabic explanation support may also be requested at this location. Other languages are available in selected cities. You can choose your preferred language support as an optional preference during registration.
How can I register for a session?
Use any Register button next to the available course dates to open the participant registration page and submit your booking request for the selected session.
Is this course available online as well as classroom-based?
Check the course schedules section for currently published classroom and Online / Live sessions.
Where are classroom sessions delivered?
Current classroom venues include Vienna, Barcelona, Rome, Munich, Amsterdam, London, Istanbul.
How long is the training programme?
The programme runs for five days from 09:00 to 14:00, which gives 25 contact hours, including a daily 30-minute break (22.5 hours of instruction).
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Choose an available date and venue, add your participants, and we will email a formal quotation for Medical Device Quality Management (ISO 13485) to your business address.