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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