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Medical Device Quality Management

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

uniPoint is proud to offer the industry’s most advanced and comprehensive suite of quality and compliance management solutions that serves the unique needs of medical device manufacturers. uniPoint software enables companies to take a risk-based approach to quality and compliance management. This allows individuals and businesses an opportunity to gain real-time visibility into the quality and document management process, and its key performance metrics.

uniPoint’s advanced and comprehensive suite of solutions for automating GXP compliance processes has embedded best practices which ensure ongoing compliance with FDA requirement, as well as other applicable regulations.

By improving operational efficiencies in compliance processes and quality systems, uniPoint software will lower the cost of regulatory compliance while creating a transparent environment for proactively identifying, tracking, and resolving quality and compliance related issues.

uniPoint uniquely combines software and content to deliver solutions for effective and sustainable compliance. These solutions are embedded with templates related to best practices, access to training content from an expert community, and integration of business processes with regulatory notifications and industry alerts.

uniPoint solutions are being used in the medical devices industry to support quality processes, and compliance requirements for risk assessment. The uniPoint Quality Management System is also extremely beneficial to management during the design and manufacturing of devices, as well as during the post-market surveillance phase.

uniPoint offers a wide variety of benefits to individuals and organizations that operate in the medical device, and life sciences community:

Faster time-to-market: Accelerate product development and completion by gaining real-time visibility into 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: Be proactive in identifying, tracking, and resolving quality issues by creating a transparent environment where decisions are based on facts and metrics.

Reduce noncompliance risk: Adopt an integrated systems-oriented approach that has compliance pre-built into the processes. This ensures you will automatically adhere to regulations and standards such as FDA 21 CFR Part 11, Part 820 Quality System Regulation and ISO 13485:2003.

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Compliance

uniPoint is a compliance tool for the strictest quality requirements of your industry.

Simplicity

Our interface promotes engaged users, and lower on-going training costs.

Integration

Eliminate redundant data entry and leverage the data from your existing systems.

Benefits

Track the frequency and cost of quality events, with our ISO-ready suite of modules.