MasterControl helps bio med device companies manage both internal and external quality management and regulatory compliance activities with a variety of customizable quality management solutions.
The medical device industry, among the most heavily regulated industries today, must contend with stringent medical device quality regulations. The FDA quality system regulation (QSR) 21 CFR Part 820 and ISO 13485 are two examples of quality regulation. Medical device quality software systems help ease the burden of regulatory compliance and give companies a competitive advantage.
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The Food and Drug Administration (FDA) regulates medical device quality based on a host of regulations, including the Quality System Regulation (QSR) outlined in 21 CFR Part 820 and Current Good Manufacturing Practices (CGMP). Medical device companies that maintain quality software systems are also covered by 21 CFR Part 11. Many medical device manufacturers, especially those that sell products overseas, also conform to ISO 13485 (Medical Devices Quality Management Systems), ISO 14971 (Medical Devices Applications of Risk Management), and ISO 9000 quality standards.
A medical device company's ultimate goal is to produce a safe, reliable, and effective product. 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 quality compliance, but sustain it year after year. The MasterControl QSR software systems for medical device quality are an integrated quality management suite of configurable, easy-to-use solutions. The system can link disconnected processes like BOM, supplier, CAPA, customer complaints, change control, document management, and more. Our medical device quality management software helps companies attain and sustain compliance with FDA 21 CFR Part 820 and other requirements, like ISO 13485, by automating and managing quality processes in an efficient and cost-effective manner.
Recognizing that validating a software solution - and keeping it in a constant state of validation - is half the battle in sustaining compliance, MasterControl has actively developed new ways to reduce the time and effort involved in validating a new system and software upgrades.
Contact a MasterControl representative for more information regarding quality control and quality assurance software for the bio device med industry.