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The Medical Devices Regulation and In Vitro Dianostic Regulation deadlines are fast approaching. Learn the requirements, timelines, and terminology you need to be prepared.

Device history records (DHRs) are the most important artifacts generated in the course of medical device manufacturing, yet many manufacturers still rely on manual, paper-based DHR systems.

Knowledge of regulatory requirements and the application of rigorous clinical investigation processes can help companies accelerate the time it takes to bring new devices to the market.

Noncompliance among medical device developers typically falls under two areas: design control and document management. These two critical elements intersect in one place: the design history file.

Review the conundrum companies are experiencing if they want to maintain both ISO 9001 and ISO 13485 certification: How to comply with the varied requirements within only one quality system.

The medical device landscape is changing, due in large part to the controversial U.S. excise tax that applies to American-made and imported medical devices.

The Food and Drug Administration (FDA) has established and maintains Part 820- Quality System Regulation (QSR), also known as 21 CFR 820 or 'Current good manufacturing practice' (cGMP).

Examine how obtaining ISO 13485 certification can open doors to untapped domestic and international business opportunities, and obtain recertification to the new revision.

The FDA’s approach to the inspection process of medical device manufacturers, Quality System Inspection Technique (QSIT), embraces a top-down inspection of a firm’s QMS.

When a company’s product development engineers and quality professionals fail to cooperate adequately, the company risks experiencing costly delays and inefficiencies.

How an enterprise quality management system (EQMS) can help you avoid 483 observations during your next facility audit.

Address the challenges most medical device manufacturers experience during the device history record (DHR) process when they aren’t properly leveraging an electronic DHR (eDHR) system.