Topic: Compliance Management
How We Do It-
5 Tips to Pass Your FDA or ISO Audit with Confidence
Three Class II medical device startup companies share their FDA and ISO inspection audit stories. Learn how these companies addressed the challenges they encountered while preparing for and going through an audit.
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Beyond Colored Folders and Spreadsheets: Maintaining the Device Master Record
Medical device manufacturers face unique obstacles in effectively managing and securely sharing their product information. Learn how automated, electronic solutions can help medical device companies better manage their device master record (DMR), design history file (DHF) and change orders.
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Medical Device Development: From Specification through Validation
Medical device manufacturers are heavily regulated organizations and rightly so. Manufacturing a potentially life-saving device should not be taken lightly. This article addresses how medical device manufacturers can leverage electronic systems to document and control the product information [...]
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Moving From Paper to Electronic Change Management
It is possible to achieve 21 CFR Part 11 compliance while implementing an electronic change management system. This article outlines five key considerations for meeting FDA regulations as you move from a paper based system to an electronic system.
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