We are ISO-13485.
ISO-13485 is a quality management system standard specific to companies in the medical sector, which includes aspects of the ISO-9001 standard and specific requirements for the medical device industry.
ISO-13485 has been harmonized in consideration of the EU MDR (Medical Devices, In Vitro Diagnostic Medical Devices and Active Implantable Medical Devices), therefore the certification according to this standard involves compliance with the specific clauses present in these directives.
The ISO-13485 certification is a tool aimed at companies that supply medical devices, both standard and custom-made, without limitations regarding the type and size of the organization.
The main objective of ISO-13485 is to reduce risk, improving patient safety.
Certification and compliance with ISO-13485 will be a competitive differentiation factor for companies. Being certified for the MD standard will increase the likelihood of reaching potential customers.
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