Project management challenges are often the greatest obstacle to overcome in the medical device development process.The GxP process management software solutions offered by MasterControl Inc. are specifically designed to facilitate medical device development by streamlining project management so companies can get their devices to market rapidly.
Throughout the process of medical device development, project managers inevitably encounter three major obstacles: regulatory constraints, resource limitations, and on-time delivery. MasterControl's integrated, user-friendly software solution suite is specifically engineered to meet the needs of companies doing business in strict regulatory environments that must comply with stringent medical device development regulations. These include regulatory requirements such as 21 CFR Part 820, the FDA’s guidelines for the regulation of quality systems related to the methods used in and the facilities and controls used for design, purchasing, manufacturing, packaging labeling, storing, installing, and servicing of a medical device.
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MasterControl's GxP process management software solutions help companies overcome these medical device development challenges by automating project management processes. Efficient task assignment and robust reporting capabilities provided by MasterControl's proven system can help project managers streamline project execution and better identify and eliminate bottlenecks. The system's filtering and project baselining features of allow medical device development teams to view tasks by category and monitor the evolution and expansion of their projects. Project workflows are dramatically streamlined since medical device development tasks are automatically updated and electronically managed by MasterControl's comprehensive system.
MasterControl integrates document and quality management with project management systems to help medical device development companies efficiently utilize resources, maintain compliance with regulatory requirements, and deliver products to market on time. By assuming the legwork of documentation and task tracking, MasterControl makes it possible for project leads to focus on the technical aspects of the project rather than the administrative components of the medical device development project.
MasterControl Inc. has been a global leader in the GxP process management field since 1993. MasterControl offers interoperable, comprehensive software solutions available individually or as a suite that allow medical device firms to achieve and maintain regulatory compliance for their products. More than 400 companies worldwide rely on MasterControl solutions to comply with the overwhelming number of regulatory requirements that pertain to medical device development firms and pharmaceutical companies. MasterControl software solutions are designed to promote companies ability to maintain compliance with ISO medical device development regulations, including:
To learn more about how MasterControl's GxP process management software can facilitate your company's medical device development processes, contact our team of experts by calling toll free at 800-825-9117 or contact us online.