ISO 13485 -standard

The ISO 13485 standard sets a frame for a quality management system for medical devices.

What is ISO 13485?

The ISO 13485 standard sets a frame for a quality management system for medical devices. The standard focuses on the requirements that an organisation must meet to indicate that the medical device and the manufactures organization and other activities comply with the requirements of the relevant regulations and the clients needs. A certified,  ISO 13485 standard compliant quality management system is a requirement – set by EU legislation (MDR, IVDR) for the manufacturers of IIa, IIb and III class devices.

Kasve’s specialists have been involved in developing, updating and auditing several quality management systems of medical device manufacturers to ensure compliance with the ISO 13485 standard. Kasve will support your organization in defining and developing your quality management system,, in identifying and describing the processes, development activities and auditing the completed quality management system. Kasve’s specialists are qualified to perform audits on ISO 13485 compliant organizations and activities (lead auditor and internal auditor qualitifications).

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