Take Charge of Medical Device Design Control Regulations with Cognition’s New White Paper Series

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Michelle Lott, Regulatory Advisor for Cognition, and Scott Wright, CEO and Founder of A Wright Path, collaborate in a series of papers to explore the effects of Design Control regulations on medical device companies

Cognition Design Control Series: Risk Management and Usability
By combining risk management with other common product development activities, Cockpit ensures risk analysis remains a consideration throughout all phases of the development process.

Cognition Corporation (http://www.cognition.us) is proud to announce a new white paper series on Design Controls. Michelle Lott, Executive Regulatory Advisor to Cognition and Scott Wright, CEO and Founder of A Wright Path, join together to create an exciting series overviewing FDA Design Control regulations as stated in 21 CFR 820.30.

The FDA requires medical device manufacturers to follow a strict set of guidelines in order to ensure compliance and safety for all devices going to market. These rapidly changing regulations are difficult to interpret which often leads to the FDA issuing Form 483s and Warning Letters to manufacturers out of regulation. This new series will aid in understanding the failures many face, as well as ways to avoid and overcome them.

After an overview of the overarching issues, it dives deeper into Risk Management and Usability when designing medical devices. The processes used in Risk Management are highlighted, including Preliminary Hazard Analyses (PHA), Failure Mode and Effects Analyses (FMEA), and Fault Tree Analyses (FTA). These processes are critical to completing a successful FDA submission and to producing a safe and effective product.

Cognition Cockpit comes with out-of-the-box templates to aid in PHAs, FMEAs, and FTAs within the product development process. “By combining risk management with other common product development activities, Cockpit ensures risk analysis remains a consideration throughout all phases of the development process,” said David Cronin, CEO of Cognition Corporation. “From early risk identification [with PHA] through to the monitoring and verification of identified risk control effectiveness.”

Get your free copy of the first white paper in the new Design Control series here.

Cognition Corporation, based in Bedford, Massachusetts, has been offering product and process development solutions for more than ten years. Cognition has two core products: Cognition Cockpit™ and Enterprise Cost Management™ (ECM). Thousands of users worldwide use Cockpit and ECM to manage their product development and to meet performance, cost, risk, and schedule targets. For more information, visit http://www.cognition.us or call +1 (781) 271-9300 or click here to schedule a live demo!

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