At Trusted Unified Verification LTD, we help medical device manufacturers, suppliers, and service providers achieve compliance with ISO 13485, the globally recognized standard for Quality Management Systems (QMS) in the medical device industry.
What is ISO 13485?
ISO 13485 specifies requirements for a comprehensive quality management system tailored to the medical device sector. It ensures that organizations meet regulatory and customer requirements related to the design, production, installation, and servicing of medical devices.
Key Benefits of ISO 13485 Certification
- Regulatory Compliance: Helps organizations meet national and international medical device regulations.
- Improved Product Safety & Quality: Ensures strict control over manufacturing and risk management processes.
- Enhanced Customer Trust: Demonstrates commitment to producing safe and effective medical devices.
- Increased Market Access: Many markets require ISO 13485 certification as a prerequisite for selling medical devices.
Who Needs ISO 13485?
- Medical device manufacturers
- Suppliers and subcontractors of medical components
- Sterilization and packaging service providers
- Organizations involved in the design and development of medical technologies
Steps to Get ISO 13485 Certified
- Gap Analysis: Evaluate current processes against ISO 13485 requirements.
- Implementation: Develop and integrate a compliant QMS.
- Internal Audits: Conduct pre-certification assessments to ensure readiness.
- Certification Audit: Undergo a formal review by our certification experts.
- Certification Issuance: Receive official ISO 13485 certification upon successful compliance.
Why Choose Trusted Unified Verification LTD?
- Expert support throughout the certification process
- Accredited and globally recognized certification services
- Continuous compliance monitoring and support
