Arabella’s first priority has and always will be patient safety. We seek to continuously improve our performance so that we always exceed our customers expectations, the patients that use our products and the regulatory authorities in the markets we operate.
To maintain our certifications, Arabella have an annual Surveillance Audit to ensure our policies and practices continue to meet the standard. There are active internal protocols in place of risk management and internal audit. As a result, customers can be confident that Arabella will provide them with the same high quality services well into the future.
CE
CE Marking on a product is a manufacturer’s declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation.
CE mark indicate that our products quality are assessed before being placed to the market according to the requirements of ISO 13485:2003(Medical devices — quality management systems — Requirements for regulatory purposes) & the requirement of medical devices directive 93/42/EEC.
They signify that products sold have been assessed to meet high safety, health, and environmental protection requirements.