Medical Consulting Srls, through its adequately trained and specialized staff, carries out consultancy activities for the adaptation and improvement of the Quality System of companies in the medical sector according to ISO 13485, ISO 9001 and EU Regulations 2017/745 (MDR) and 2071/746 (IVDR).
The services offered include:
- Consultancy for the construction, maintenance and updating of the company QMS and internal processes.
- Conducting audits, pre-audits and gap analysis to verify compliance of the QMS with the requirements of the country of interest
- Adaptation of the company QMS to the requirements of the country of interest
- Support for the validation of processes and special processes (Sterilization, decontamination, washing, surface treatment, welding)
- Validation of the Quality Management System software