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Showing items tagged as design control

  • 2018-bl-thumb-how-to-approach-design-control

    How to Approach Design Control From Both FDA and ISO Viewpoints

    Design control plays a key role in producing a successful medical device or IVD tool in initial development and through its lifecycle. Learn some tips on how to approach a design control strategy from either FDA or ISO perspectives.

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  • 2019-bl-thumb-socra-associations-tie-in

    Bill of Materials Can Help Relieve Pain Points in Device Design Approval

    Nothing can result in more frustrations for a medical device manufacturer than the complexities and headaches that occur during the product design approval process. But by developing a comprehensive bill of materials (BOM) strategy that boosts design control, your organization can avoid pitfalls and increase the turnaround time of deliverables.

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  • 2018-bl-thumb-top-5-med-device-industry-trends-software complex

    Top 5 Medical Device Industry Trends in 2018: Software Is More Common and Complex

    The inclusion of software in medical devices is opening up new avenues for health care treatments. However, it also means medical devices are becoming more complex. New innovations in medical device development should compel device manufacturers to revamp their design and development strategies. More time and effort needs to be spent on design control, risk management and cybersecurity. The increase of software in medical devices will a noticeable impact on the approaches to medical device design and manufacturing.

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  • Med Device: How to Address the Documentation Burden of Design Control

    Design control issues represent a key challenge for many medical device firms. This is the reason why in 1996, the U.S. Food and Drug Administration (FDA) added design control principles to 21 CFR Part 820 and required rigorous documentation to demonstrate design control.

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  • Quality by Design Part 1: You Can't Design Something You Don't Understand

    Just like every other aspect of a product, quality is determined by the decisions you make in the design stages. While spending less time on planning upfront might seem to save you money, the costs associated with poor quality resulting from early design decisions can ultimately equate to 40 percent of your company’s total revenue. Correctly understanding the true nature of quality and addressing it in the design stages rather than trying to bring it in as an afterthought is the central premise of Quality by Design (QbD), and adhering to this principle could be the most cost-saving measure your company will ever take.

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