Quality Management System Software Medical Device

Qms requirements for medical devices are defined by regulatory agencies in their regulations and in the international standard iso 13485 medical devices quality management systems requirements for regulatory purposes.

Quality management system software medical device.

Medical device startups have a pile of things to address yet often don t have the pile of money to take care of everything that is needed. The qualityze eqms software for medical devices is a closed loop quality system which includes document management change management nonconformance management capa management audit management training management complaints management supplier quality management calibration management maintenance management with exciting features like audit trail electronic signature validations dashboards reports and analytics. Manufacturers of finished medical devices made or sold in the united states must comply with gmp regulations enforced by the u s. Assurx medical device manufacturing quality management software qms is designed to balance the complexity of global quality management and regulatory requirements while maintaining a high level of flexibility to adapt to continual industry and operational changes.

The importance of medical device quality management systems in fda and iso environments. In simple terms a medical device quality management system qms is a structured system of procedures and processes covering all aspects of design manufacturing supplier management risk management complaint handling clinical data storage distribution product labeling and more. Unipoint is leading edge quality and compliance management software for the medical device aerospace automotive or general manufacturer. Successful life science companies utilize assurx s seamlessly integrated software to centrally monitor manage and improve their quality and regulatory compliance related processes across all operations and product lifecycle.

The quality system regulation or qsr 21 cfr 820 contains essential requirements that apply to medical device manufacturers and it is the primary medical device regulation that the fda enforces. Harmonized with iso 13485. Medical devices quality management systems. Food and drug administration fda.

In today s market leading medical device companies are implementing turn key modern quality management software solutions that enable closed loop traceability clt between design controls risk document and quality event workflows such as capa audit nonconformances and complaints.