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  ISO 21500 and Medical Device Development

  ISO 21500 and PMI provide guidance for Medical Device Development and Project Management Officer at StarFish Medical.

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  ISO 10993-1 FDA Change Could Significantly Impact your Biocompatibility Plans

  ISO 10993-1 and Biocompatibility impact on Medical Device Plans. Financial impact of additional Medical Device testing will have a cost.

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  What does the Abbot Glucose Meter recall tell us about Risk Analysis and Verification Testing?

  Medical Device innovation and new product features must be balanced with an equally intense focus on Risk Analysis and Verification Testing.

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  7 Tips for Efficient Medical Device Submissions to IEC 60601 Edition 3

  Seven tips for a smooth and successful outcome.to IEC 60601 Edition 3 submissions and electrical safety testing

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  Benefits of Positive On-Site Inspection for Medical Device Development Companies

  Preparation for our medical device development and contract manufacturer On-Site inspection helped our client earn a successful Factory Inspection.

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  Managing Expectations in Medical Device Development

  How to manage medical device development expectations to keep development team, investors, and funding agencies all on the same page.

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  Embracing Failure in the Medical Device Industry

  Embracing Failure means exploring the value in ‘failing fast’ and acknowledging failures and their causes in medical device development.

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  Can Innovators Implement?

  Can you do innovative medical device product development without the right complement of innovators and implementors?

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  Diversity & Innovation, Problem Solving Methodologies in Medical Device Design

  Diversity & Innovation in the team dynamics of a medical device design team are an essential part of the development process.

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