Consulting, education and auditing

SIGMA SYSTEMS providing consulting, education and auditing services through:

1. 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,
2. services and consulting related to Information security controls within Information security management systems, cybersecurity, data and privacy protection, development and implementation of cybersecurity requirements.
3. services and consulting related to development and implementation of artificial intelligence within artificial intelligence management systems,

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.

Duration: from one month to six months

Targets and sectors: regulatory support for medical device industry in following: 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.

Goal: Company certification according to ISO 13485, MDSAP, ISO/IEC 27001, ISO/IEC 42001, etc. and Medical device certification according to MDR / IVDR and FDA regulations.

Phases: few phases or steps

Activities in each phase: All project phases are according to PDCA process approach.

Expected outcome: Company processes and medical device are compliance with standards and regulations.

Process and mode of implementation: support by experts - online or on-site when is necessary.