Quality Management Systems - Requirements for Regulations

ISO 13485 is the only management systems standard solely developed for manufacturers of medical devices. The standard outlines specific requirements for the design and manufacture of medical devices and provides a harmonized outline of the regulatory requirements deemed necessary for a Quality Management System (QMS). Similar to ISO 9001 in its application, IS0 13485 requires certified organizations to demonstrate the implementation and maintenance of a Quality Management System. However, ISO 13485 calls for specific requirements only inherent to the medical device community. This includes the adoption of a Risk Management program, dedicated processes for validation and the demonstration of operating product traceability and recall systems.

Impact

Medical Device manufacturers that adopt IS0 13485 typically realize many benefits beyond compliance. By implementing and maintaining an effective QMS, device manufacturers can confidently deliver quality products to market. Indirectly, manufacturers can also expect to gain improved customer relations, reduced operating costs and safer working environments. Adoption of this standard will also prove beneficial for manufacturers seeking to improve their Risk Management efforts. Although not designed as a prescriptive guideline for the application of Risk Management for medical devices (see: ISO 14971), ISO 13485 requires risks to be managed throughout the lifecycle of a product.

Challenge

Medical Device manufacturers looking to adopt the guidelines outlined in ISO 13485 often find the process difficult. Disorganized spread-sheet applications, disparate silos of risk-related records and untraceable data prevent manufacturers from demonstrating that they can successfully implement and manage a Quality Management System.  Without the right solution, manufacturers subject themselves to a diverse set of risks – many of which can impair their ability to remain competitive in the market place.

The Dyadem Solution

Dyadem provides comprehensive Quality Risk Management (QRM) solutions that enable global Medical Device companies to reduce risk management effort by 50%-80%. In addition to improved quality and reduction in compliance risks, Dyadem also offers an integrated lifecycle model linking all parts of design and production risk analysis. This provides full traceability for FDA compliance and the identification of critical quality attributes to align design with manufacturing.