We offer customised consulting for the preparation and/or maintenance of the company’s quality system in accordance with the requirements of the Medical Device Regulation and the IVD Regulation and/or in accordance with the requirements of ISO 13485.
In cooperation with the company’s personnel, we will prepare the most appropriate procedures and data recording systems to meet the mandatory requirements, while ensuring that these are well integrated with the company’s reality, for a QMS that is effective and company-wide.
If the company already has a QMS in place, we can trace together the path for its optimisation, in order to eliminate unnecessary redundancies and superstructures, and configure more efficient operational practices.
