More than 20,000 companies worldwide produce over 80,000 brands and models of medical devices for the U.S. market. A company's success in this highly competitive and dynamic market depends on continuous innovation, rapid product development, and the ability to respond to market needs in a cost-effective and clinically relevant manner. The medical device industry, one of the most heavily regulated industries in existence, must also contend with stringent GxP regulations in order to stay in business.
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The Food and Drug Administration (FDA) regulates GxP processes in the medical device industry based on a plethora of regulations, including the Quality System Regulation (QSR) outlined in 21 CFR Part 820, Current Good Manufacturing Practices (CGMP). Companies that utilize electronic record-keeping systems must also maintain compliance with 21 CFR Part 11, which is predicated on FDA GxP requirements. Many medical device manufacturers, especially those that sell products overseas, must conform to ISO 13485(Medical Devices Quality Management System Requirements for Regulatory Purposes), ISO 14971 (Medical Devices - Application of Risk Management to Medical Devices), and ISO 9000 standards. Public companies or those companies that are planning to go public or are acquired by public companies are subject to Sarbanes-Oxley Act (SOX) requirements as well. These are just a few of the GxP regulations that medical device developers must contend with as a product moves from development to commercialization.
A medical device company's ultimate goal is to produce a safe, reliable, and effective product in a timely manner while staying ahead of the competition and staying in compliance with GxP requirements. To achieve this goal, the company must address many challenges, including:
Compliance is a state, not an event. A medical device company must not only attain compliance, but sustain it year after year. The MasterControl™ integrated process management and document management suite is a configurable, easy-to-use solution that helps companies attain and maintain compliance with FDA, ISO and other regulations by automating and managing GxP processes in an efficient and cost-effective manner. This connectivity helps improve communication between departments, promotes quality and compliance throughout the enterprise by allowing managers to continuously monitor and proactively improve all GxP processes throughout the entire product development lifecycle. Some of these key processes include:
MasterControl makes it possible for medical device developers to meet key GxP requirements and ISO standards while also increasing efficiency and keeping compliance costs down. MasterControl helps companies to recognize GxP compliance as a part of the corporate culture by enabling compliance to be enforced across the enterprise in every department. By connecting company personnel with relevant data and processes, everyone is able to see the big picture. The result is an environment that fosters collaboration and allows managers to visualize and monitor all product development processes as a unified system.
Recognizing that validating a software solution and keeping the software in a continuous state of validation is half the battle in maintaining compliance, MasterControl is actively developing new ways to reduce the time and effort involved in validating a system based on the risk of each individual company.
In order to get more comprehensive information regarding medical device process management and document management software solutions, feel free to contact MasterControl representative.