Standard ISO 13485
Quality Management System – Medical Devices
The quality assurance of medical devices is vital to ensure compliance with regulatory requirements and requirements of customers.
These issues are covered by standard ISO 13485.
ISO 13485:2016 will help you detect critical points and set up and monitor individual processes to ensure the continuous quality of medical devices, including their design, production, assembly and maintenance.
ISO 13485:2016 is recommended to companies and organizations whose activities involve medical devices in any stage of the supply chain.
Requirements of ISO 13485
Reduction of operational costs
•Implementation of extensive requirements for medical facilities
•Definition and monitoring of relevant processes in view of legal requirements
•Validation of processes
•Assuring traceability of products
Benefits of the Certification
Assuring the necessary quality of medical devices in the entire supply chain
•Improved risk detection and better solutions
•Greater trust of your clients
•Compliance with all legal and regulatory requirements
Successful audit represents verification of correctly implemented and well-functioning management system based on ISO 13485.
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