Quality and compliance
Arclight devices are designed and manufactured to internationally recognised quality and regulatory standards
With ISO 13485 certification and global regulatory registrations, we provide dependable medical devices trusted by healthcare professionals worldwide.
ISO 13485:2016 certified quality management system
We hold ISO 13485:2016 certification for our quality management system, covering the design, development, and manufacture of our ophthalmoscopes and otoscopes, awarded by BSI (British Standards Institution).
ISO 13485:2016 is the internationally recognised standard for medical device quality management systems. This certification demonstrates that we meet stringent global requirements for safety, reliability, and consistency—across product design, manufacturing, and distribution.
📄Download our ISO 13485 certificate
Regulatory compliance
Our products are classified as Class I medical devices and comply with applicable regulatory requirements in the markets we serve.
We maintain comprehensive technical documentation and conformity assessments to support compliance and market access.
European Union – CE marking
Our devices meet the requirements of EU medical device regulations.
We are registered in EUDAMED.
- EUDAMED SRN: UK-MF-000042204
United Kingdom – UKCA marking
Our products meet UK medical device regulatory requirements and are registered with the MHRA (Medicines and Healthcare products Regulatory Agency).
- MHRA registration number: 25609
United States – FDA registration
Our devices are registered with the U.S. Food and Drug Administration (FDA) in accordance with applicable requirements for Class I medical devices.
- FDA establishment registration number: 3034205503
Our approach to quality
Beyond certification, we are committed to maintaining a robust and transparent quality system. This includes:
- Full product traceability and documentation
- Ongoing risk management and design control
- Post-market surveillance and continuous improvement
- Rigorous testing to ensure durability and clinical usability
Our goal is to ensure that every Arclight device delivers dependable performance—wherever it is used.
Ethical standards & responsible sourcing
We are committed not only to product quality, but also to operating responsibly and ethically across our entire supply chain.
Modern slavery statement
We are committed to preventing modern slavery and human trafficking in all aspects of our business and supply chain.
📄View our modern slavery statement
Supplier & distributor code of conduct
We set clear expectations for our partners regarding ethical practices, labour standards, environmental responsibility, and compliance with applicable laws.
Company information
Arclight is the brand name of St Andrews Medical Innovations Ltd (SMI), a company registered in Scotland.
- Company number: SC705314