Medical Devices Industry

While medical device manufacturers develop increasingly sophisticated healthcare technologies, they also have to deal with a growing range of quality and safety risks across the product lifecycle. Alongside, regulatory scrutiny has intensified in recent years with a spate of new compliance requirements and reforms.

MetricStream GRC Solutions for the Medical Devices Industry integrate and map together regulations, risks, quality processes, audits, and incidents in a common environment, resulting in improved risk visibility and accountability. The Solutions also streamline and automate quality and compliance management workflows, enabling you to better monitor product safety and quality across the enterprise and supply chain, while enhancing compliance with multiple regulations, and reducing compliance costs.

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MetricStream GRC Solutions for the Medical Devices Industry

MetricStream offers a comprehensive range of Solutions that enable medical devices companies to facilitate an integrated, closed-loop, and consistent approach to product and supplier quality, compliance, audits, policy management, and risk management.

With embedded best practice templates, automated workflows, powerful reporting tools, and regulatory content alerts, our Solutions enable you to enhance quality and compliance, while mitigating risks in a timely manner.

Leading companies are replacing their point solutions and paper-based systems with MetricStream Solutions to improve visibility into product safety, efficiently comply with multiple regulations, enhance accountability and traceability across the supply chain, and strengthen confidence in their quality and safety processes.

Benefits

  • Strengthen compliance with FDA GXPs, ISO 13485:2003, and other medical device regulations and standards.
  • Accelerate product releases with real-time visibility into quality, performance, and risk metrics.
  • Enhance medical device quality by creating a transparent environment where quality issues are proactively identified and resolved.
  • Reduce non-compliance risk. Adopt an integrated systems-oriented approach that has compliance built into quality systems.
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