Quality Management System Software Medical Device

Manufacturers of finished medical devices made or sold in the united states must comply with gmp regulations enforced by the u s.

Quality management system software medical device.

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. Unipoint is leading edge quality and compliance management software for the medical device aerospace automotive or general manufacturer. 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. Harmonized with iso 13485.

Validate computer software for its intended use when used as part of production or the quality. 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. 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 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.

The trusted quality management system software for medical devices product development with qualio helps you meet design control requirements of iso 13485 and fda 820 regulations and provides a clear view of your development processes from needs to verifications to validations. 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. Because of this a medical device quality system often gets pushed to the back burner in favor of activities that are perceived to add more value and meaning to the startup. The importance of medical device quality management systems in fda and iso environments.

Medical devices quality management systems.