Quality and Regulatory

Quality & 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 supply only quality-assured products that are CE marked under the Medical Device Directive (MDD) and EU Medical Device Regulation (MDR) and UKCA marked under the UK Medical Device Regulations (UK MDR 2002, as amended), 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 comply with the essential requirements of the Medical Devices Directive (MDD 93/42/EEC) and the General Safety and Performance Requirements (GSPR) of the EU Medical Device Regulation (MDR 2017/745), allowing us to place the CE mark on our products. We are subject to annual audits by our EU notified body, SGS Belgium (NB 1639), to verify ongoing compliance with applicable standards and regulations.

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

For further information see our Resources Section