Regulatory Compliance & Quality Standards

Aura Medical is committed to supplying ophthalmic products that meet the highest standards of regulatory compliance, quality assurance, and patient safety. The products we distribute are manufactured and certified in accordance with recognised international and UK medical device regulations.

UKCA Certification

Products supplied by Aura Medical carry the UKCA mark where applicable, demonstrating compliance with regulatory requirements for medical devices placed on the market in Great Britain.

CE Marking

Many of the products within the Aura Medical portfolio are CE marked, confirming conformity with European safety, health, and environmental protection standards for medical devices.

ISO 13485 Quality Management

Our manufacturing partners operate under ISO 13485 certified quality management systems, the internationally recognised standard for the design and manufacture of medical devices.

UK Medical Device Regulations (UK MDR)

Products distributed by Aura Medical comply with the UK Medical Device Regulations 2002 (as amended) and other relevant regulatory requirements governing the supply of medical devices in the United Kingdom.

Commitment to Quality

Aura Medical works with established global manufacturers to ensure that products supplied to NHS hospitals, private clinics, and ophthalmic surgeons meet strict regulatory and clinical standards.

Regulatory Documentation

For product-specific regulatory documentation, declarations of conformity, or certification information, please contact the Aura Medical team.