Medical Devices

Medical Device Regulation


medical device regulation

The medical devices industry in general represents areas whose activities are carried out under a high level of quality assurance and within a very strict regulatory framework.
Any organization, medical device industry aims to ensure that the safety, efficacy and quality of products / services placed on the market are respected. Achieving this objective requires the establishment of a quality management system integrating good manufacturing practices and risk management within the organization.
Do you have too much paperwork? Are you wasting too much time maintaining the document system? Having trouble tracking deviations and changes? Do you take a lot of time to manage audits? Do you have a problem following the equipment calibration and qualification schedule? ...
EQMS Qualipro is the ultimate solution to facilitate and optimize the management of the quality system. This through its different modules in compliance with the requirements of GMP, the ISO 9001 standard as well as the CFR PART 11 and the NF EN ISO 13485.

Benefits of EQMS Qualipros

  • 1 Electronic documentation management (electronic signatures, version management, systematic withdrawal of obsolete versions, etc.).
  • 2 Management of staff skills and training schedules.
  • 3 Change management
  • 4CAPA and deviations management
  • 5Automation of validation flows.
  • 6Real-time monitoring of the achievement and effectiveness of planned actions.
  • 7Audit management from planning to automatic generation of audit reports.
  • 8Management of measuring equipment, automatic generation and monitoring of the calibration schedule and qualification of equipment.
  • 9Management of suppliers, supplier complaints and supplier assessments.
  • 10Monitoring of performance indicators in real time, automatic generation of dashboards.
  • 11Customer feedback management through the processing of complaints and satisfaction.
  • 12Management of non-compliant products at different stages of detection.
  • 13Management of meetings as well as the automatic generation of meeting minutes
  • 14Risk management.
  • 15Management of interested parties.
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