Medical Device Regulations

Medical device manufactures are constantly pushing the boundaries of innovation, and delivering more powerful products. The rapid pace of growth requires a robust system to ensure that regulatory obligations and reporting requirements are being met.

Today maintaining and managing compliance has become more of an enterprise-level risk management challenge than just a departmental initiative. As one of the most closely scrutinized sectors, the medical device industry has a list of strict compliance mandates such as FDA GXPs , international device safety standards, marketing laws,  and cross-industry compliance requirements such as SOX . At the same time, the industry has to implement the changes that are being made to existing regulations.

MetricStream Compliance Solution for Medical Device Companies:

MetricStream offers the industry's most advanced and comprehensive quality and compliance management solution that serves the unique needs of medical device manufacturers. The solution enables companies to take a risk-based approach to quality and compliance management, and gain real-time visibility into the quality and document management process along with key performance metrics.

The solution automates  GXP compliance processes, and provides embedded best practices that ensure compliance with FDA medical device regulation requirements as well as other applicable regulations. By improving operational efficiencies in compliance processes and quality systems, the MetricStream solution lowers the cost of regulatory compliance, and creates a transparent environment for proactively identifying, tracking, and resolving quality and compliance related issues.

Through a distinct blend of software and content,the MetricStream solution enables organizations to implement effective and sustainable compliance. The solution is embedded with best practice templates, provides access to training content from an expert community, and integrates business processes with regulatory notifications and industry alerts.

MetricStream solutions are widely used in the medical device industry for supporting key quality and compliance requirements for risk assessment and management during the design and manufacturing of devices as well as during the post-market surveillance phase.

Benefits of the MetricStream Solution

Faster Product Development Cycle: The solution provides real-time visibility into quality, key performance metrics,and document management processes to accelerate product release and time-to-market.

Lower Costs : The solution builds operational efficiencies in quality systems, thus reducing the cost of regulatory compliance and poor quality.

Enhanced Product Quality: A transparent environment is created where quality issues are proactively identified, tracked, and resolved. Better decision-making is enabled based on the facts and metrics captured by the system.

Reduced Non-compliance Risk: The solution enables an integrated systems-oriented approach where compliance is embedded in systems and processes to adhere to regulations and mandates such as FDA 21 CFR Part 11, Part 820 Quality System Regulation, and ISO 13485:2003.