GMP for Medical Devices (ISO 13485)
An introduction to quality and regulatory requirements for medical devices. Participants learn ISO 13485:2016, risk management to ISO 14971, the EU MDR and US FDA QMSR framework, and the documentation needed to place a device on the market and keep it compliant.
At a glance
- 2 days
Who it's for
- People new to the medical device or diagnostics sector
- Pharma staff working with combination products (e.g. inhalers)
- QA/RA staff
Learning objectives
- Understand the regulatory framework for manufacturing and marketing medical devices
- Apply ISO 13485 QMS requirements
- Use ISO 14971 risk management and vigilance systems
- Understand documentation needed to market and keep a device compliant
Detailed content
- EU MDR 2017/745 & IVDR 2017/746
- US FDA QMSR (aligned with ISO 13485, effective
- Feb 2026)
- Local authority registration (e.g. EDA, SFDA)
- QMS & documentation
- Design controls
- Production & process controls
- CAPA & complaint handling
- ISO 14971:2019 process & tools
- Technical documentation
- Post-market surveillance & vigilance
Day-by-day agenda
A typical schedule. In-company versions are tailored to your processes, data and timing.
- Regulatory Framework
- ISO 13485:2016 Requirements
- Risk Management
- Marketing & Post-Market
- Case study, action plans and course assessment
Practice, tools and assessment
Hands-on practice
- Build a HACCP plan for one product: flow diagram, hazards, CCPs, limits
- PRP/GMP inspection walk with nonconformity reporting
- Traceability and mock-recall exercise
- Mock regulatory inspection of a GMP area
Tools and templates you keep
- HACCP plan worksheets (hazard analysis, CCP decision tree)
- PRP/GMP inspection checklist
- Mock-recall record
- Deviation, CAPA and change-control forms
How learning is assessed
- Pre- and post-course knowledge check
- Assessment of practical exercises by the trainer
- Action plan reviewed at the end of the course
Built on these standards and bodies of knowledge
- Codex Alimentarius CXC 1-1969 (General Principles of Food Hygiene, 2022)
- ISO 22000:2018 and FSSC 22000 v6
- BRCGS Food Safety Issue 9 / IFS Food 8
How it is delivered
- Public courses in Cairo, in-company programs and live online training
- Practical exercises, case studies and examples from your sector
- Can also run as Train & Stay in Sharm El Sheikh, Hurghada or Cairo
Part of these career paths
Frequently asked questions
How long is GMP for Medical Devices (ISO 13485)?
The program runs 2 days. In-company versions can be adapted to your needs.
Is the course taught in Arabic or English?
Sessions are usually delivered in Arabic with English technical terms and materials. Full English delivery is available for in-company groups.
Can you run it inside our company?
Yes. In-company programs use exercises built on your own processes. Tell us the group size and preferred timing and we will send a proposal.
Will I receive a certificate?
Participants who complete the program and its assessment receive a certificate from The Excellence Center, which can be verified online.
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- Good Laboratory & Good Manufacturing Practices (GLP + GMP) Workshop5 days
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- Pharmaceutical Clean Rooms & HVAC: Design, Qualification and Monitoring4 days
- Pharmaceutical Water Systems: Principles & Practice2 days
Get dates, fees and the full outline.
Tell us whether you are joining as an individual or planning a program for your team.