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30 min ago 2 min read
Germany-based Witt-Gasetechnik has secured a key quality certification for its medical gas technologies, strengthening its position in oxygen-compatible systems and opening the door to wider use in regulated healthcare environments.
The company has been awarded ISO 13485:2016, confirming it develops and manufactures products for medical applications in line with recognised regulatory requirements.
Its components comply with ISO 15001 for oxygen compatibility and are suitable for use in systems designed to EN ISO 7396 for medical gas pipeline infrastructure. Products are also available with FDA-approved elastomers.
The latest regulation is widely regarded as a prerequisite for suppliers in medical technology, underpinning approvals, audits and procurement decisions.
Witt said the certification will allow customers to integrate its products more easily into regulated environments, particularly where ISO 13485-compliant supply chains are required.
The company is already active in the sector, supplying gas mixers for synthetic air and gas analysers for medical gases, including its MED MG mixers and Oxybaby Med analysers.
With certification now in place, Witt plans to expand its medical portfolio to include additional gas technology components. This will cover safety-critical equipment such as non-return valves, safety valves and gas pressure regulators.
The certification scope includes the design, development, manufacture, marketing and servicing of gas safety equipment, as well as gas detection and control systems for medical applications.
Witt said its internal processes, including risk management, traceability, validation and documentation, meet the specific requirements of the medical technology sector.
