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 Belgium 1639 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. Altomed’s products conform to Medical Devices Regulations 2002 (SI 2002 No 618, as amended) and hold the UKCA mark for all products. We are annually audited by our notified body SGS UK 0120 to ensure compliance to applicable standards and regulations.
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 & Other Resources
- UKCA Certificate
- ISO 13485 Certificate
- Altomed CE Certificate Annex II
- Altomed Limited CE1639 Corrigendum
- Altomed CE Certificate Annex V Page 1
- Altomed CE Certificate Annex V Page 2
- MHRA Registration
- Latex Statement
- LSP 01 Labour Standards Policy
- GDPR 03 Privacy notice for website
- Terms and Conditions of Sale
- Whistleblowing Policy
- LSAS Newsletter 2022
For further information see our Resources section.