The introduction of a quality management system according to the EN ISO 13485 is often the start in the world of the medical device industry. This harmonized standard builds a solid ground for medical device manufacturers aiming for conformity assessment to achieve CE marking.
Furthermore, it is suitable for companies specialized in customized production and departments focusing on in-house production as well as service providers and suppliers in the field of medical technology.
MDSS Consulting GmbH offers competent support for the development, documentation and maintenance of a functioning QM system.
Our goal is the implementation of a customized system based on your products and requirements, which supports your employees in their daily work and reflects all processes in a manner conforming with the directives.
Only this way it is guaranteed that, in the end, your products can be delivered to your customers in the required consistent high quality.
We will be happy to integrate additional requirements such as GMP, FDA requirements, local requirements for your target countries or a risk management process.
If you like to receive further information, please use our contact form. The MDSS Consulting GmbH team is looking forward to hearing from you!