Medical Devices
Medical device manufactures are constantly pushing the boundary of innovation and delivering more powerful products. The rapid pace of growth also requires robust systems to ensure regulatory obligations and reporting requirements are being met.
Regulatory requirements include FDA GXPs and reporting mandates, international device safety standards and marketing laws, and cross-industry compliance requirements stipulated by laws such as Sarbanes Oxley Act (SOx). Compliance is evolving from an isolated departmental initiative to an enterprise level risk management challenge.
MetricStream offers industry's most advanced and comprehensive suite of quality and compliance management solutions that serves the unique needs of medical device manufacturers. MetricStream enables companies to take a risk-based approach to quality and compliance management as companies gain real-time visibility into the quality and document management process and its key performance metrics.
MetricStream's advanced and comprehensive suite of solutions for automating GXP compliance processes has embedded best practices that ensure ongoing compliance with FDA requirement as well as other applicable regulations. By improving operational efficiencies in compliance processes and quality systems, MetricStream lowers the cost of regulatory compliance and creates a transparent environment for proactively identifying, tracking and resolving quality and compliance related issues.
MetricStream uniquely combines software and content to deliver solutions for effective and sustainable compliance with embedded best practices templates, access to training content from an expert community, and integration of business processes with regulatory notifications and industry alerts.
MetricStream solutions are widely being used in the medical devices industry for supporting key quality processes and compliance requirements for risk assessment and management during design and manufacturing of devices as well as during post-market surveillance phase.
Faster time-to-market: Accelerate product development and release by gaining real-time visibility in the quality and document management process and its key performance metrics.
Reduce costs: Lower the cost of regulatory compliance and the cost of poor quality by building operational efficiencies in quality systems.
Improve product quality: Proactively identify, track and resolve quality issues by creating a transparent environment where decisions are based on hard facts and metrics.
Reduce noncompliance risk: Adopt an integrated systems-oriented approach that has compliance built into systems and processes to adhere to regulations and standards such as FDA 21 CFR Part 11, Part 820 Quality System Regulation and ISO 13485:2003.
