Regulating Medical Devices Shapes Industry for the Better
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Regulating Medical Devices Shapes Industry for the Better
This article originally appeared in Business Worldwide magazine. It’s fashionable to be anti-regulation in business today. But sometimes regulation is central to how a sector operates. We talk to Rita King, CEO of MethodSense and Russ King, President of MethodSense about why regulating medical devices and biotech/pharma companies is so critical. Most devices and innovations…
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Take the Document Control System Quiz (SPOILER: it’s pass/fail there’s no partial credit)
How do you know your Document Control System is working properly within your medical device company? Take this quick Document Control Health Check-Up Questionnaire: If you answered, without hesitation, “Yes!” to all these questions, you are in great shape. Congratulations! If you answered “No” or “Maybe”, or if you had to pause and really think…
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5 Questions to Evaluate your Records v. Documents Management Practices
Documents, documents everywhere. But which are the records, which are documents, what is the difference and why does it matter? Even start-up medical device companies are neck deep in documentation. In addition to documents generated during the creation and production of a product or combination device, additional documentation is generated while working with the FDA…
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What’s the Right Quality Management System software?
Quality Management System Software The medical device industry is a highly regulated environment that requires a stringent adherence to quality. So, you need a QMS software that helps you manage the project process to enhance team collaboration, reduce time to market, and manage critical information that can be immediately accessed. But with so many QMS…
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Maintain Document Control
Medical Device Document Management & Control Medical device document management and control is essential for an effective quality management and regulatory compliant system, especially as your product pipeline expands toward commercialization goals. To meet these challenges head on, it’s vital to manage information across your entire operation, ensuring regulatory compliance including: FDA 21 CFR Part…