WITT-Gasetechnik has been certified to ISO 13485:2016.
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This certification confirms that the company develops and manufactures products and components for medical applications in accordance with recognised regulatory requirements. These products comply with ISO 15001 “Anaesthetic and respiratory equipment — Compatibility with oxygen” and they are suitable for use in systems designed to EN ISO 7396 “Medical gas pipeline systems”. They are also available with FDA-approved elastomers.
The ISO 13485 certification as a formal proof of quality is a prerequisite in many areas of medical technology and facilitates the use of WITT products in medical environments. This provides customers with additional assurance and benefits their own quality assurance processes – particularly where ISO 13485-compliant suppliers are required for their approvals or audit processes.
WITT is already established in the medical sector with specialised products such as gas mixers for synthetic air (MED MG) and gas analysers for medical gases (OXYBABY Med). With this new certification, the company will be able to offer further gas technology components for medical applications in future, including safety-related components such as non-return valves, safety valves and gas pressure regulators.
ISO 13485:2016 is the internationally recognised quality standard for organisations that manufacture products or components for medical applications. It sets out requirements for documented, traceable and risk-based processes and forms the basis for approvals and supply relationships in numerous markets.
The certificate covers the design, development, manufacture, marketing and servicing of gas safety equipment, as well as gas detection and control equipment for medical applications. It confirms that internal processes – including risk management, traceability, validation and documentation – meet the specific requirements of the medical technology sector.