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  Battery safety for medical devices

  Overview of battery safety for medical devices addressing design issues related to size, form, capacity and performance demands on batteries.

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  How much does it cost to develop a medical device?

  The amount of total company funding to develop a Class II 510(k) cleared medical device is approximately $30 million. The development and engineering costs comprise approximately $2-5 million of this total. This estimate is built upon a meta-analysis of various references as well as our experiences in engaging with companies. Many factors influence these costs, including the need for clinical studies, regulatory pathway, and technology complexity. Refinement of these numbers requires a professional team to understand the technology, regulatory, and business opportunities.

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  Consider these 3 areas carefully when testing medical devices in a Biolab

  Testing Medical Devices in a Biolab? Pre-planning is required for specialized tests, potentially dangerous microorganisms, tissues and biological fluids.

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  How to Turn Patient Imaging Data Into Functional 3D Models

  How to create accurate and functional 3D models from patient imaging data. Develop anatomically accurate prototypes for medical device design.

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  Planning and Conducting Summative Usability Testing

  There are a lot of things to consider when creating a summative usability test. The first time can be overwhelming. What scenarios do I test? How do I identify a critical task? How many participants do I need? Do I need to test the training? In this eGuide I will help you avoid common mistakes, like using a formative test structure for a summative usability test. I will also provide some tricks and tips to help you get the most out of your test participants and testing.

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  Advice from a former Deputy Director FDA/CDRH Office of Compliance and FDA Investigations

  Interview with Larry Spears, Former Deputy Director FDA/CDRH Office of Compliance and FDA Investigations on prep for regulatory submissions.

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  Describing StarFish: Client satisfaction

  Results of StarFish client satisfaction survey with a large group that included customers and prospects using one word descriptions.

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  7 Digital Hospital Trends for 2014

  7 Digital Hospital Trends to look for in 2014 and keep abreast of technological advancements for surgical skills and clinical relevance.

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  5 Things You Should Know About Making a Medical Device Manufacturable

  Making a medical device manufacturable is a common scope of work. 5 ‘make it manufacturable’ suggestions for medical devices.

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