Training
Professional Regulatory, Quality & Compliance Training
Patient Guard provides practical, industry-focused training courses designed for medical device manufacturers, IVD companies, quality professionals and organisations seeking to strengthen regulatory and management system knowledge.
Our training courses are delivered by experienced regulatory and quality professionals with real-world industry expertise across medical devices, in vitro diagnostics, quality management systems and compliance frameworks.
Whether you are new to regulatory requirements or looking to improve internal competence within your organisation, our training programmes provide clear, practical and actionable guidance aligned with current industry expectations.
Our Training Courses
ISO 14971 Risk Management Training
Learn the principles of medical device risk management in accordance with ISO 14971 and understand how to implement effective risk management processes throughout the product lifecycle.
- Risk management planning
- Hazard identification
- Risk analysis and evaluation
- Risk control measures
- Benefit-risk analysis
- Post-market risk management
- Risk management documentation
- Medical device manufacturers
- QA/RA professionals
- Design and development teams
- Start-ups and innovators
EU MDR Training
Gain a practical understanding of the European Medical Device Regulation (EU MDR 2017/745) and its requirements for manufacturers, importers, distributors and authorised representatives.
- MDR structure and requirements
- Device classification
- General Safety and Performance Requirements (GSPR)
- Technical documentation
- Clinical evaluation
- Post-market surveillance
- Economic operators
- UDI requirements
- Medical device manufacturers
- Regulatory professionals
- Importers and distributors
- Start-up companies
EU IVDR Training
Understand the key requirements of the In Vitro Diagnostic Medical Device Regulation (EU IVDR 2017/746) and how to achieve compliance for IVD products.
- IVDR overview
- Classification rules
- Performance evaluation
- Technical documentation
- PMS and vigilance
- Quality management system expectations
- Regulatory responsibilities
- IVD manufacturers
- Regulatory affairs professionals
- Quality professionals
- Importers and distributors
ISO 13485 Basic Training
Develop a clear understanding of ISO 13485 and the requirements for establishing and maintaining a medical device quality management system.
- ISO 13485 structure
- Quality management principles
- Documentation requirements
- Risk-based approaches
- Supplier controls
- CAPA
- Internal audits
- Management review
- Medical device companies
- QA professionals
- Start-ups
- Employees new to ISO 13485
ISO 9001 Basic Training
Learn the fundamentals of ISO 9001 and quality management system principles applicable across a wide range of industries.
- Process-based approach
- Risk-based thinking
- Quality objectives
- Documented information
- Internal auditing
- Continuous improvement
- Customer focus
- Businesses implementing ISO 9001
- Quality teams
- Managers and employees
- Organisations seeking certification
ISO/IEC 27001 Basic Training
Gain an introduction to information security management systems and the key requirements of ISO/IEC 27001.
- Information security principles
- Risk management
- ISMS structure
- Annex A controls
- Security awareness
- Compliance obligations
- Continuous improvement
- Organisations handling sensitive data
- Compliance teams
- IT and security personnel
- Businesses pursuing ISO 27001 certification
Training Formats
We offer flexible training delivery options to meet the needs of individuals and organisations.
- Live online instructor-led training
- Private company training sessions
- Group workshops
- Customised training programmes
Why Choose Patient Guard?
- Experienced regulatory and quality professionals
- Practical industry-focused training
- Clear and easy-to-understand delivery
- Training aligned with current regulations and standards
- Support for manufacturers, start-ups and established organisations
- UK and EU regulatory expertise
Corporate & Team Training
Patient Guard also provides private training sessions tailored to your organisation’s products, processes and regulatory requirements.
- Medical device manufacturers
- IVD manufacturers
- Start-ups
- Quality and regulatory teams
- Importers and distributors
Please contact us to discuss customised training solutions for your organisation.
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Request Training Information
To enquire about upcoming courses, private training or customised programmes, please contact Patient Guard.
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