TrackWise for the Medical Device Industry

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With TrackWise your organization can achieve a state of efficient compliance. Manage all quality applications using a single system while reducing cost of quality.

Medical device manufacturers are faced with the challenges of adhering to regulatory requirements, decreasing their products' timeto- market, lowering the risk of product recalls and reducing overall costs to quality.

Device manufacturers must comply with good manufacturing practices (GMPs) and 21 CFR Parts 808, 812 and 820 of the quality system regulation, which address expectations to produce, design, and document quality processes. These regulations are consistent with quality system requirements worldwide.

As a result of these demands the Medical Device industry is faced with the need to accurately manage, track, and trend a vast number of quality (GxP), safety, and regulatory compliance issues.

Nonconformance, supplier quality management, complaints, MDRs, internal and third party audits and observations, corrective and preventive actions (CAPA), change control, design control, and document management are critical processes for any medical device organization. A streamlined and reliable Quality Management System can reduce a company's compliance risk exposure, reduce the cost of quality and enable it to achieve a competitive advantage.

More and more companies are adopting a harmonic approach to implementing a single, integrated platform which can provide an effective and scalable solution to all of the above needs. This includes selecting a tool that can easily assimilate additional applications and requirements without requiring substantial expenditure of additional "modules", licensing costs, time or resources.

TrackWise is a fully configurable software tool that provides a robust, scalable, flexible, stable, and simple to use solution for managing and tracking all compliance needs, involving all departments including Manufacturing, QA, Engineering, and Product Surveillance.