VD MAIS confirms compliance with ISO 13485:2016 (Medical Devices)

15.08.2023 |

ISO 13485:2016VD MAIS has obtained the ISO 13485:2016 certification for the production of electronic modules, supply of electronic components, and printed circuit boards for medical devices.

The company VD MAIS has confirmed its compliance with the international standard ISO 13485:2016. This standard is one of the most crucial international norms that regulates quality management systems for medical devices. It establishes requirements for quality management systems that can be applied by organizations involved in the design, development, production, assembly, and servicing of medical devices, as well as in the design, development, and provision of services related to them. In comparison with the general ISO 9001 standard, the specialized ISO 13485 for developers and manufacturers of medical devices sets more stringent requirements for validation, production management, metrological support, personnel management, and documentation.

The certificate issued to VD MAIS covers the area of production of electronic modules, supply of electronic components and systems, printed circuit boards, measuring equipment, equipment, and materials for production, as well as servicing of electronic modules and systems, measuring equipment, and machinery.

VD MAIS has experience in manufacturing modules for defibrillators, cardiographs, lung ventilation systems, patient monitors. Thanks to technical support from leading manufacturers, market knowledge, and modern trends, our engineers can offer the customer optimal solutions for processing and transforming medical signals.

The company first received the certificate for the current version of the standard in 2016 and has been updating it every 3 years since, demonstrating compliance with the requirements. The certificate is issued by one of the leading European certification bodies, Quality Austria.

The certificate is recognized by the international certification network IQNET.