ISO 27001 -standard
ISO 27001 is an internationally well-known information security standard.
ISO 27001 is an internationally well-known information security standard. The standard defines requirements for the construction, implementation, maintenance and continuous improvement of an information security management system. The standard also sets requirements for assessing and processing information security risks. Thanks to its international renown, the standard also serves as a competitive advantage in the market for medical devices.
Kasve’s specialists will help you understand the ISO 27001 requirements, particularly in the context of the medical devices market. We will help you as you take the first steps in designing your system, identifying and describing critical processes, and the overall development of management systems and auditing techniques.
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We have helped a number of medicinal device manufacturers, testing and clinical laboratories, and start-ups develop their operations.
IEC 60601 -standard
IEC 60601 is a series of technical standards that describes the requirements for the safety and essential performance of medical electrical equipment.
IEC 62304 -standard
IEC 62304 defines the set of processes for life-cycle management of medical device software.
ISO 13485 -standard
The ISO 13485 standard sets a frame for quality management systems for both medical device manufacturers and other organisations in the chain.