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  How eLearning and LMS Empower Medical Device Employees

  elearning and LMS improve an employee’s ability to learn and adhere to the company QMS for medical device design and development.

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  Sharing and Using SuperPowers and Kryptonite

  Our SuperPowers and Kryptonite program will continue to develop over time. It fosters a culture where people are inspired and able to do the most fulfilling work of their lives.

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  Bio Break: The Van Halen Secret to Medical Device Safety

  Nick and Joris dive into the surprising connection between rock bands and medical device safety. What do jelly beans and 1980s rock legends Van Halen have to do with developing safe and effective medical technologies? More than you might think.

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  Bio Break: Funding Strategies for Medical Devices

  Nick and Joris tackle a topic that’s more relevant than ever—raising funds for medical device development in today’s challenging financial landscape. With economic headwinds and cautious investors, startups and even established organizations face significant hurdles in securing funding. But there are ways to mitigate these challenges, and Joris shares strategic insights to align product development milestones with fundraising cycles.

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  Validating Filter Integrity for Biopharmaceutical Manufacturing

  Filter Integrity Biopharmaceutical Manufacturing explores the relationship between microbial retention tests and integrity tests essential for validating the effectiveness of filters in critical applications.

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  FDA Guidance on Biocompatibility Evaluation ISO 10993-1

  Review of FDA Guidance on Using ISO 10993-1 integrating biocompatibility evaluation within the risk management process, as outlined in the FDA Guidance Document  Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process.

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  Service Design in Medical Device Development

  Integrating service design with user-centered design when developing medical devices can enhance device usability, efficiency, and outcomes.

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  Tips for “Voice of the Customer” Medical Device Research in Low- and Middle-Income Countries

  7 Tips for conducting Voice of Customer medical device research in Low- and Middle- Income Countries (LMICs) is an integral component in user-centric design and development. It is increasingly an expectation of regulatory bodies.

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  Sensory Design for Medical Devices

  The medical devices in the masthead above have vastly different purposes. One thing that’s common is they all have some combination of sensory aspects. Sensory design uses affordances (perception of design features intuitively suggesting a functional task) and semantics (conveying meaning and information about the product’s use and function through sensory cues). Both can be communicated through our five senses with the most common being visual, tactile and auditory.

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