Quality Management System
Supporting Excellence in HealthTech Design and Quality Assurance
ISO 13485 Compliance and Management for Medical Devices
Understanding ISO 13485
ISO 13485 is the international standard for quality management systems in the medical device industry. It provides a comprehensive framework for:
- Organisations involved in any stage of the medical device lifecycle
- Related service providers
The standard ensures consistent quality, safety, and efficacy of medical devices.
Key Aspects of ISO 13485
- Implementation of a robust quality management system
- Continuous monitoring and improvement
- Integration with business operations
- Support for UK MDR & EU MDR compliance
- Focus on patient safety and risk management
Our ISO 13485 Expertise
Our team offers extensive experience in ISO 13485 compliance, including:
- Development and management of quality management systems
- Internal and external audit support
- Tailored guidance for your organisation’s specific needs
ISO 13485 Management and Compliance Services
We provide comprehensive support for:
Assessment and Planning
- ISO 13485 gap analysis
- Quality Manual production
Implementation
- Process and procedure definition
- Work instruction development
Audit and Certification
- Internal audits (NQA certified team members)
- External audit preparation and support
Continuous Improvement
- Ongoing system maintenance
- Process optimisation aligned with your organisations existing processes
Harmonised Standards Integration
Our approach aligns ISO 13485 with other crucial standards:
- UK MDR
- ISO 62304
- ISO 14971
Benefits of Our ISO 13485 Services
- Ensure regulatory compliance
- Improve product quality and safety
- Enhance operational efficiency
- Strengthen market competitiveness
- Facilitate global market access
Partner with our experienced team to navigate the complexities of ISO 13485 compliance and elevate your medical device quality management system to industry-leading standards.