Quality Management

Producers that design and sell Medical Devices on the European market need to have a quality system which is both efficient and that meets the regulatory requirements. ISO 13485 is a quality system that conforms to the regulatory requirements as stipulated in the Medical Device Directives.

Implementing a quality system

Implementing a quality system, with documented routines and responsibilities and at the same time fulfil all regulatory requirements takes time and effort. It is not so easy to document the obvious or even know in which detail it needs to be documented. For many manufactures it is often difficult to see how you shall be able to fulfil all requirements and at the same time be efficient. DOCMAN has helped several customers to fulfil requirements and at the same time create a quality system with relevant documented routines and processes.

Sustain an efficient quality system

If you already have a quality system and need support to fulfil new regulatory requirements, DOCMAN can offer you that support. Typical support can be assessment of regulatory requirements for new products/markets, internal reviews or a commitment as your part time quality manager.