ISO 13485:2016
Medical Devices – Quality Management System
Standard brief
An ISO 13485:2016 certificate creates a global acceptance and reputation for companies in medical sector including manufacturers, storage, semi-finished product and service suppliers provides certification ISO 13485:2016 medical devices quality management system certification services. – medical quality management system with its experienced staff. ISO 13485 has already been tested and proven. Companies that have achieved certification can show proof to potential clients that they comply with best practices, and with regulatory requirements.
Benefits
- Improve customer satisfaction.
- Improve your processes.
- Improve decision-making.
- Create a culture of continual improvement.
- Better employee engagement.
- Reduced cost of sales
Concepts
- Quality Management System.
- Medical Device File
- Design and Development Process of Medical device
- Medical Device Life Cycle
- Product Traceability – Medical Device Tracking
- Software Integrations of the Medical Device
ISO Certification
ISO 9001:2015
Quality Management Systems for all organisations of all sizes from all domains. Learn More
ISO 14001:2015
Environment Management Systems to ensure minimal environmental impact. Learn More
ISO 45001:2018
Occupational Health and Safety Management Systems for people safety. Learn More
ISO 22000:2018
Food Safety Management System to ensure safe food practices for your customers. Learn More
ISO 27001:2013
Information Security Management System for securing your organisation's information. Learn More
ISO 20000-1:2018
Information Technology - Service Management System to assist with smooth IT services. Learn More
ISO 13485:2016
Medical Devices - Quality Management System to ensure quality medical products. Learn More
ISO 17025:2017
Requirements for Testing and Calibration Laboratories to demonstrate competent operations. Learn More
ISO 50001:2018
Energy Management System framework to manage and reduce energy use and costs. Learn More
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