Si Global Consulting Company

Si Global | Safety, Quality, and Compliance Solutions Si Global specializes in management systems consulting and training services, offering high-standard solutions. With our expert team, we provide customized support tailored to the needs of various industries, contributing to the success of our clients. Below, you can find more detailed information about the solutions and services we offer. Expertise in the Railway Sector With over 20 years of experience, we provide consultancy services for the implementation and optimization of Safety Management Systems (SMS) in compliance with the provisions of Directive (EU) 2016/798. The services we offer include: • Risk Analysis and Management • Independent Safety Assessment • Compliance with CSM, CSM-RA, and CST • Approval Bodies/Processes such as NoBo, DeBo, AsBo, ISA, ICE, IVE • Audits and Inspections • Accident and Incident Investigations • Training Each service is designed to contribute to railway safety and security, ensuring that the industry meets the highest safety standards. Additionally, by collaborating with National Safety Authorities (NSAs), we monitor the change management and compliance processes and ensure adherence to national regulations. Expertise in the Medical Device Sector With over 30 years of experience, we serve as a reliable partner in compliance with the 93/42 EEC Medical Device Directive, MDR 2017/745 Medical Device Regulation, and EN ISO 13485 standards. The services we offer include: • CE Certification • Design Controls Activities Management (DHF) • Preparation of Product Technical Files • Risk Management (ISO 14971) • Biocompatibility (ISO 10993, ISO 18562) • Usability / Formative & Summative Studies • Sterilization Validation (EO, Gamma) • Packaging Validation • Process Qualification • Validation (IQ-OQ-PQ) • PMS, PSUR, PMCF • Clinical Evaluation • Training By contacting us, you can learn more about our customized solutions tailored to your needs.