SigmaTech Nordic

SigmaTech Nordic and our partner company; Sigma Systems, offer specialized services in certification of medical applications and devices (CE marking), implementation and training related to Quality Management (ISO 13485), Risk Management (ISO 14971), Software Life-Cycle processes (EN 62304), Cybersecurity (ISO 27001 & EN 81001-5-1), Quality Assurance (QA) outplacement, and acting as an Authorized Representative for non-EU manufacturers. SIGMA SYSTEMS is certified according to ISO 13485 and ISO/IEC 27001. SigmaTech Nordic is acting as a site location. The scope of Quality Management Systems is the provision of 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. You are always welcome to reach out and contact us by email: info@sigmatechnordic.com