Medical device
VTU is a professional partner for both manufacturers and suppliers of medical devices.
VTU supports you to etablish a quality management system in accordance with the international standard ISO 13485.
Distributors, manufacturers and technical analysts of medical devices have to apply to strict legal regulations and examination by the authorities before being permitted market access.
The directives 93/42/EWG, 98/79/EWG and 90/385/EWG (MDD Medical Device Directive) represent the standards required on the European and Swiss markets. In the case of international sales, legal regulations including those applicable in the USA (FDA), Brazil (ANVISA) and Japan (PAL) have to be taken into consideration too.
In all cases, a well-established quality management system must be implemented and for class I (measurement devices, sterile items), class II and class III products. The quality management system has to be audited by a notified body.
The standard ISO 13485 applies to distributors, manufacturers and technical analysts of medical devices and was first introduced in 2003. The standard defines the organisational specifications for the development and manufacture of medical devices based on the standard ISO 9001 including also specific amendments. “Medical Devices Market Surveillance” and the “Improvement and Avoidance Measures System” have replaced the aspects “Customer Satisfaction” and “Continual Improvement”.
Our medical technology experts will advise you on how to improve production processes and implement the regulatory requirements for process validation. Based on your value creation process we develop a costumized quality management system and work with you every step of the way, right through to successful certification. This allows you to concentrate your efforts on your core competencies while also benefiting from a range of quality management tools which provide optimum support in your day-to-day operations.
