Topic: Quality and Compliance

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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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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When product quality problems are managed in a system independent of the complete product record, fixing identified quality issues is slow. Plus, audits are a challenge, with no automatic link between the problem and the fix.

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Training record management is a major element of quality management, compliance, and regulatory practices as well as employee safety. The benefits gained from implementing these three steps of training record management automation are realized quickly, span across cross-functional departments, and aren’t limited to just audits.

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Using a compliant Quality Management System with a CAPA subsystem, your company will be ahead of the 465 companies with CAPA related FDA 483s. You will be compliant and maintain compliance with less anxiety and overhead.

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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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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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