ISO 13485 - Medical devices
ISO 13485 is the international standard for quality management systems for those who produce and / or distribute medical devices.
The assessment of quality management systems for medical devices, focuses on the design, production and distribution of the medical devices and the service offered to the customer, by imposing strict requirements that ensure better control of processes.
The implementation of a quality management system has as positive effect the definition of efficient controlled processes and workflows, together with the recognition of an international certification, especially when it is combined with the marking of its products.
If the CE marking of your products is requested, CSI can offer you an integrated certification service (system and product) working in collaboration with IMQ group, to which it belongs. The company is notified for the Medical Device Directive and acts as the unique interlocutor for the customer.
As ISO 13485 standard encloses the requirements of ISO 9001, you can integrate both certifications.
ISO 13485 certification issued by CSI will allow to:
• Communicate your quality standards
• Gain a competitive advantage thanks to an independent certification
• Take advantages of our long laboratory experience
• Use the recognition of a Notified Body (IMQ) for the certification of your medical devices