The introduction of a QM system supports those involved in the field of medical devices in the systematisation of processes, but also in the implementation of their legal or contractual obligations. EN ISO 13485 was created for this purpose. It is aimed specifically at organisations that deal with medical devices and associated services. The requirements of the standard include product safety, documentation and verification (e.g. traceability) and appropriate risk management. EN ISO 13485 is so flexible that individual processes can be designed and optimised according to individual specifications, while at the same time ensuring compliance with the regulations for handling medical devices.
Accredited certification also attests that the audited QM system is capable of fulfilling the requirements placed on the company’s organisation.
The certification of this system by mdc not only serves the effective external presentation, but also the further development within a company. Experienced auditors with up-to-date training are available to carry out the audits. Of course, certification in accordance with EN ISO 9001 completes our portfolio.
A certified QM system is an advantage in the face of increasing international competition.