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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

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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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  Tips for Developing Medical Devices With Software

  Developing medical devices with software involves a wide-ranging set of unique challenges. Our software engineering team offer advice on offered advice on software in medical devices, FDA, Software as a Medical Device (SaMD), risks, cybersecurity, and Open Source software.

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  9 Ways to Use AI in Medical Device Development

  9 ways to use AI in medical device development from our experts include Connected Medical Devices, QA/RA, Developing (real time) Simulations, Expedite Design Process, Analysis and Research, Supplier Evaluations, Project Reviews, Brainstorming, and Administrative Help (Faster than Google).   

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  Six Project Manager Skills for Success in the Medical Device Industry

  A Project Manager navigating this complex medical device development landscape requires the ability to marry traditional Project Management Skills with the specificity of medical device industry practices that focus on patient outcomes and regulatory requirements. This article includes 5 skills that expert project manager, Shalaka Maind, deems crucial to medical device development success.

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  9 Biggest Productivity Drains and Their Solutions

  Can’t get your medical device development work done on time? We crowdsourced this dilemma to our employees, and they shared their biggest productivity drains and solutions. Spoiler alert: there were nine drains and five of them share the same solution.

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