SG Medical established an efficient Quality Management System (QMS) designed to fulfil the highest level of complexity of class 3 medical devices with a large range of reliable and efficient quality solutions.
From incoming controls to final inspection, SG Medical ensures the full traceability of the medical device manufacturing which range from complex single use devices to sub-assemblies’ batches.
SG Medical is an ISO 13485 certified company which complies with the highest MedTech regulatory standards (ISO, CE, FDA...) and works exclusively with certified suppliers and partners.
Our ISO 13485 certified processes are designed to deliver successes at all stages of a product's life cycle from pilot line to high volume GMP manufacture and logistics.
Our Class 7 and 8 cleanrooms are also compliant with ISO 14644 (Cleanrooms & associated controlled environments).
Our internal Quality Management System is audited annually and verified by our independent certification body, Bureau Veritas, to prove conformity with international standards, ISO norms and regulatory requirements to help our clients bring safer products to the market.
SG Medical QMS is implemented in all daily operations performed by our employees and management.
In order to meet these ongoing objectives, SG Medical quality policy is focused on:
- Compliance with relevant international standards and regulatory requirements
- Customers’ satisfaction and follow-ups
- Internal ongoing trainings
- Infrastructure and resources reliability and availability