Our commitment
Quality & certifications
Every SG Manufacturers device is designed, manufactured and tested within a certified quality management system, so clinicians and distributors can trust what they hold.
Medical devices QMS
Quality management system for the design and manufacture of medical devices.
Quality management
Internationally recognised standard for consistent quality management.
European conformity
Declaration of conformity for placing devices on the European market.
Electrical medical equipment
Safety and essential performance requirements for the electrically powered video laryngoscope.
EU MDR 2017/745
Compliance with the European Medical Device Regulation for the EU market.
Our commitment
Quality Never Die
Quality is not a department at SG Manufacturers, it is how we work. From incoming material inspection to final release, every batch is traceable and every device is tested against defined acceptance criteria. Our processes are audited regularly to keep our ISO 13485 and ISO 9001 certifications current, and our regulatory team maintains the technical documentation needed for EU-MDR (2017/745) and CE market access.
- ISO 13485Medical devices QMS
- ISO 9001Quality management
- CEEuropean conformity
Need a certificate?
Verified partners can request our ISO, EU-MDR and CE documents through the resource centre. Requests are reviewed and released via the Distributor Portal.