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  Core competencies of a medical device project manager

  Medical device project manager core competencies are explored using Topgrading to identify and hire medical device professionals.

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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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  Toyota, SOUP, and Medical Device Software of Unknown Provenance

  Ways to safely handle Medical Device Software of Unknown Provenance and third party code in Medical Device Development.

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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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  Drawing Ponies and IEC 62366

  Using a design approach to investigate the user’s needs provides a head start on ISO 60601 Ed. 3 and IEC 62366 medical devices

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  Smart Approach to Medical Device Product Development

  Smart approach to Medical Device Product Development. It is very difficult to leapfrog the iterative design process.

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  Dobson’s “Check” list to attract Medical Device Investment

  To attract Medical Device Investment, planning and managing people and resources towards measurable goals is as important as the technology.

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