Support in QMS Implementation

The MDR states in Article 10 (9), the requirements for the Manufacturer’s QMS. Despite not being specified, ISO 13485 is the most suitable quality management systems standard for medical devices companies. To effectively implement ISO 13485, manufacturers (and other economic operators) need to use documentation to control their internal processes. IPN assists manufacturers identify/create the necessary processes and to develop/update the associated documentation to prove compliance with this standard. The documentation is not restrictive and is adapted to each organization. So, in order to meet the requirements and also operators’ specific needs, IPN team work closely with each section or department representatives. After designing an implementation plan, IPN team helps companies build their QMS in order to prepare them for a certification audit