Quality and Regulatory

The high quality of our products is founded on our quality management system which ensures patient safety and compliance with all relevant regulations, rules, standards and laws.

We only supply quality assured CE marked products manufactured to internationally recognised standards.

Our high standards and attention to detail are reflected throughout the company from our manufacturing sites through to quality inspection, packaging, sterilisation and the onward supply to the end user.

Altomed’s products conform to the essential requirements of the EU Medical Directive 93/42/EEC, allowing us legally to place the CE mark on our products. We are annually audited by our notified body SGS 0120 to ensure compliance with the applicable standards and directive. We are registered and regulated by our UK Competent Authority, the MHRA, as a manufacturer of medical devices.

We also operate a full quality management system which is audited to meet international standard ISO13485:2016, the world’s most widely recognised quality management system standard for medical devices, allowing us to continually monitor and manage our company procedures and quality across all our operations.

Certificates

For further information see our Resources section.