Planned further expansion in the medical technology division

3 May 2026

WITT receives ISO 13485 certification

WITT-Gasetechnik has been certified in accordance with ISO 13485:2016. This certification confirms that the company develops and manufactures products and components for medical applications in compliance with recognised regulatory requirements. These products comply with ISO 15001 “Anaesthetic and respiratory equipment – Compatibility with oxygen” and are suitable for use in systems designed in accordance with EN ISO 7396 “Medical gas pipeline systems”. They are also available with FDA-approved elastomers.

 

As formal proof of quality, ISO 13485 certification is a prerequisite in many areas of medical technology and facilitates the use of WITT products in medical environments. It also provides customers with additional assurance and benefits for their own quality assurance processes – particularly where suppliers meeting ISO 13485 requirements are required for approval procedures or audits.

 

WITT already has a presence in the medical sector, offering specialist products such as gas mixers for synthetic air (MED MG) and medical gas analysers (OXYBABY® Med). With this new certification, the company will in future be able to offer additional gas technology components for medical applications, including gas control equipment and safety components such as non-return valves, safety valves and gas pressure regulators.

 

ISO 13485:2016 is a globally recognised quality standard for organisations manufacturing products or components for medical applications. It defines requirements for documented, traceable and risk-based processes and serves as a foundation for approvals and supplier relationships across many markets.

 

The certification covers the design, development, production, marketing and servicing of safety fittings and gas detection and control devices for medical applications. It confirms that internal processes – including risk management, traceability, validation and documentation – meet the specific requirements of the medical technology sector.

 

More information is available at: www.wittgas.com

Read more:

PARTNERS