Showing items tagged as medical device design

  • Software as a Medical Device – Upcoming Changes to the Australian Regulations

    July 17, 2020 by Belinda Dowsett, Quality Assurance Manager and Consultant

    So much can change over a nearly 20 year period. Since the Australian Regulatory Framework for medical devices was adopted in 2002, the use and accessibility of software in medical applications has advanced beyond expectation.

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  • What Verification and Validation Activities are Required for a First in Human Study?

    June 23, 2020 By Lynessa Erler, Director of Product Testing at MPR Associates, Inc.

    Manufacturers preparing for a first in human (FIH) study of a new medical device face questions. Learn answers about what verification and validation activities are required for a FIH study.

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  • Establishing a Robust Human Factors Engineering Process in Development

    April 23, 2019 by Tressa Daniels, Senior Manager of User Experience Design and Human Factors Engineering, Becton Dickinson

    Human factors engineering (HFE), also called usability engineering, in an essential part of user experience design and a major component in ensuring that human well-being and system performance are optimized. Learn why device manufacturers can best benefit from HFE processes when they are integrated into the existing product development phase.

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  • 2019 Med Device Trends to Watch For: Human Factors Engineering

    March 6, 2019 by Cindy Fazzi, Staff Writer, MasterControl

    To err is human, but if medical device manufacturers can mitigate hazards associated with user errors, so much the better. The U.S. Food and Drug Administration (FDA) requires human factors engineering (HFE) in device development precisely for this reason. Expect HFE to be more important than ever, according to industry experts

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  • How to Transition to the EU’s Medical Device Regulation

    November 19, 2018 By Mike Rigert, Staff Writer, MasterControl

    Preparing for compliance with the European Union’s (EU) Medical Device Regulation (MDR) is proving challenging for medical device manufacturers. Learn how to be prepared in this Blog Series, starting with Part 1.

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  • Airplane Preflight Check Exemplifies Quality in Med Device Design

    October 10, 2018 by David Jensen, Staff Writer, MasterControl

    Before any aircraft leaves the ground, it undergoes a preflight check. Part 2 of this series on BraveHeart features Steve McCalmont performing an aircraft preflight check to illustrate how this critical part of flying equates to the importance of incorporating quality in the design of a medical device.

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  • 7 Ways That Medical Device Design Control Helps the Design Engineer

    August 28, 2018 by Edwin Waldbusser, Medical Device Regulatory Consultant, Medical Device SOP Advisors

    The design and development of a medical device can be fraught with surprises and challenges for the design engineer. Learn how to avoid these hiccups by implementing solid design controls that can help the process run smoother, and better yet, see the device ready on-time and on-budget.

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

    August 9, 2018 by David Jensen, Staff Writer, MasterControl

    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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  • Is Supplier Quality a Fallacy? Implement Risk-Based Control in Design

    July 3, 2018 by Walt Murray, MasterControl Consulting Partner and Principal Consultant of Pinpoint Consulting

    Medical device manufacturers must rely on more than their buyers or procurement group to provide supply quality. In order to be successful, companies must implement risk-based design controls in order to minimize risk and maximize benefits to their supply quality process.

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  • Top Medical Device Trends in Asia-Pacific and Around the World

    May 15, 2018 by Terry Walsh, Director APAC, MasterControl

    The speed at which the medical device industry is changing and evolving is perhaps unrivaled in the life sciences industry. Medical device manufacturers are experiencing disruption from small companies and startups entering the market1, tech giants like Amazon are investigating and investing in medical device expertise and cybersecurity concerns are on the rise.

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  • Human Factors: Why it is Critical in Designing Medical Devices

    April 18, 2017 David Jensen, Staff Writer, MasterControl

    “Most of the time spent wrestling with technologies that don’t quite work yet is just not worth it for end users, however much fun it is for nerds.” 

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  • Top 5 Takeaways from MedTech Intelligence’s Medical Device Cybersecurity Conference

    April 11, 2017 David Jensen, Staff Writer, MasterControl

    I recently attended a conference on Medical Device Cybersecurity hosted by MedTech Intelligence held March 23-24, in Washington, DC. It’s evident that cybersecurity is an important concept as attendance, both in-person and remote, was high. Conference organizers lined up a powerhouse group of presenters who are all entrenched in the technology, cybersecurity, legal and regulatory compliance industries.

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