The implementation of a quality system is an added value for companies and a guarantee of quality for their clients.
The international standard ISO 13485 is the reference standard for the management quality system, specific for companies that operate in the medical sector. The standard specifies the requisites for the system of management of the quality of the organizations that operate both in design and production of medical devices, as well as of the design and supply of correlated services. Our specialized team have the recognized specific knowledge of ISO 9001 and ISO 13485, and are able to support companies in the implementation of:
- Quality systems, also in the request for certification,
- Quality manual and related SOPs:
- Risk Management Plan (RMP);
- Management of relations with the certification institution;
- Assistance during the audit.
Moreover, we also provide the quality responsible person in outsourcing. responsabile qualità in outsourcing.