Medical Devices
Medical device companies are constantly pushing the boundary of innovation and delivering new more powerful products. The rapid pace of growth in the medical device industry also requires robust systems to ensure regulatory obligations and reporting requirements are being met.
Regulatory requirements medical device companies face today include FDA GxPs and reporting mandates, international device safety standards and marketing laws, and cross-industry compliance requirements stipulated by laws such as the Sarbanes Oxley Act. Compliance is evolving from an isolated departmental initiative to an enterprise level risk management challenge.
InfoStrength’s Smart Enterprise Suite offers the industry's most advanced and comprehensive suite of quality and compliance management solutions that serves the unique needs of medical device companies. InfoStrength's Smart Enterprise Suite ensures ongoing compliance with FDA requirements as well as other applicable regulations. By improving operational efficiencies in compliance processes and quality systems, InfoStrength’s Smart Enterprise Suite lowers the cost of regulatory compliance and creates a transparent environment for proactively identifying, tracking and resolving quality and compliance related issues.
Medical device companies further enjoy as part of the integrated suite of InfoStrength Smart Enterprise Suite functionality the ability to manage the complex operational path towards commercialization with control of every stage of product development with robust project and process management.
InfoStrength’s Smart Enterprise Suite is being used in the medical devices industry for supporting key quality processes and compliance requirements from risk assessment and management during design to post-market surveillance phase. Medical device companies also use the project and process management capabilities to manage R&D, device design and control processes, vendors as well as all the intellectual property generated by the process of innovation.
Medical Device Challenges
For a Medical Device company developing a new device, the ultimate goal is to ensure the safety, reliability, and high quality of the product. To achieve this goal, the company must address many challenges, including:
- Inefficient Systems: Medical Device companies with multiple facilities typically have independent, hybrid systems and even paper-based systems in place. In the long term, however, these systems are inefficient, requiring tremendous man-hours in terms of routing SOPs and other documentation, obtaining approval and signatures, face-to-face meetings to discuss changes, and manual search and retrieval of documents during FDA inspections. Infostrength Smart Enterprise Suite is designed to incorporate the whole company at the enterprise level, while maintaining each division’s independent workflow.
- Contract Manufacturing: As more companies rely on Contract Manufacturers to bring their products to market, it is important that the systems implemented allow for increased visibility downstream. Infostrength Smart Enterprise Suite provides integration at multiple levels of the process, allowing contract manufacturers to take part in the overall medical device industry, without direct access to the main system. This allows the Contract Manufacturers to fill in their pieces of the process, and provide a seamless Quality Management System, from start to finish.
- High Cost of Validation: As required by 21 CFR Part 11, a secure environment must be maintained, and the medical device industry must be validated to maintain electronic signature integrity. As a result, validation services can double or even triple the cost of a software system. Infostrength Smart Enterprise Suite is designed specifically for the medical device industry, and our staff has developed the test scripts necessary to ease system validation. Because Infostrength Smart Enterprise Suite is usable right out of the box, and configurations are executed at the server level, the need to extensive validation across the enterprise is less than comparative systems in the market.
Key benefits realized by InfoStrength customers include
- 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.
- Reduced costs:
Lower the cost of regulatory compliance and the cost of poor quality by building operational efficiencies in quality systems.
- Improved product quality:
Proactively identify, track and resolve quality issues by creating a transparent environment where decisions are based on hard facts and metrics.
- Reduced 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.
What Solutions Are You Looking For?
Learn how InfoStrength SES provides solutions for the Medical Devices industry.