Welcome to TUV United, your trusted partner in achieving excellence through ISO 13485:2016 certification. ISO 13485:2016 is an international standard specifically designed for quality management systems (QMS) in the medical device industry. It ensures compliance with regulatory requirements and demonstrates a commitment to the highest standards of quality and safety in medical devices.
ISO 13485:2016 Certification Services
Welcome to TUV United, your trusted partner in achieving excellence through ISO 13485:2016 certification. ISO 13485:2016 is an international standard specifically designed for quality management systems (QMS) in the medical device industry. It ensures compliance with regulatory requirements and demonstrates a commitment to the highest standards of quality and safety in medical devices.
Benefits of Certification with TUV United
Some of the Industries that can benefit the most
Certification Process
Steps for Implementing ISO 13485:2016
- Gap Analysis: Assess your current processes against ISO 13425:2016 requirements to identify gaps.
- Quality Manual Development: Develop a comprehensive quality manual outlining policies, objectives, and responsibilities.
- Documentation: Create or update documentation to comply with the standard’s requirements, such as quality policy, objectives, and procedures.
- Risk Management: Implement risk management processes to identify, assess, and mitigate risks associated with medical device quality.
- Design and Development Controls: Establish controls for the design and development of medical devices to meet customer requirements and regulatory standards.
- Validation and Verification: Develop criteria for supplier selection and monitoring, implement production controls, and conduct validation activities to ensure products meet specified requirements.
Benefits of Implementing ISO 13485:2016
- Enhanced Quality Assurance: Ensures the consistency and reliability of medical devices through rigorous quality management practices.
- Regulatory Compliance: Meets regulatory requirements and facilitates market access for medical devices globally.
- Improved Efficiency: Streamlines processes, reduces waste, and enhances overall operational efficiency.
- Enhanced Customer Confidence: Builds trust with stakeholders, healthcare professionals, and patients through adherence to stringent quality standards.
- Risk Management: Identifies and mitigates risks throughout the product lifecycle, ensuring safety and reliability.
- Market Access: Facilitates entry into international markets by demonstrating compliance with global regulatory requirements.
The Application Process
When To Apply? Just finish your management system implementation
How To Apply? Contact us
- Info@
- 0225256863
- Building 83,105 St. Maadi Cairo, Egypt
