Sigma Systems offers a wide range of regulatory services, expert guidance and support for medical device companies, ensuring compliance and regulatory success.

SIGMA SYSTEMS is certified according to ISO 13485 and ISO/IEC 27001.

Scope of SIGMA SYSTEMS QMS/ISMS is providing consulting, education and auditing services through:

--> regulatory services and consulting within the medical devices quality management systems,

--> competence management, knowledge management, learning and e-learning, assessment of learning services and people development outcomes,

--> services and consulting related to Information security controls within Information security management systems, cybersecurity, data and privacy protection,

to clients in the medical device industry which includes regulatory support in research, design and development of medical and in vitro diagnostic medical devices, software as medical device (SaMD), development and maintenance of QMS and eQMS, support during launching on the market and support in production and post-production processes.

SIGMA SYSTEMS

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