Topic: Quality and Compliance

Most product quality problems are fixed by changing the product record—the product design and the documentation that describes how to manufacture, test, and package the product.

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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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An FDA or ISO audit is a necessary and potentially difficult part of doing business for any medical device manufacturer. For startup medical device manufacturers the first audit of your processes can be as nerve-racking as the first time you defended your business plan before venture capitalists, submitted your first 510(k) application, or delivered your product to market.

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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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Medical device manufacturers are heavily regulated organizations and rightly so. Manufacturing a potentially life-saving device should not be taken lightly. It can take years to get a product to market given the required research, development and rigorous testing that takes place.

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The Device Master Record (DMR) is an all-encompassing collection of documents and records (including device specifications, process specifications, quality assurance procedures, and packaging and labeling specifications) mandated by 21 CFR Part 820.181.

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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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