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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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  Teamwork in Medical Device Development

  Medical device development teamwork evolves out of team members’ hard work, focus and the right approach to project management..

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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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  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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  Winning Project Management Practices for Medical Device Development

  Medical device design, development and manufacturing are no trivial business. These project management communication practices are essential to success!

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  Errata – or – That’s Just Plain Codswallop!

  When designing medical devices, use trustworthy data sources! Reading the manufacturer’s spec sheets and errata is not sufficient for problem-free design.

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  FDA Recognized Standards List Number 30 for Medical Devices

  Updated FDA Recognized Standards for use in premarket reviews of medical devices with declaration of conformity to consensus standards.

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  Medical Device Internal Auditing – Making Friends with “Bad News”

  Medical Device Internal Auditing is vital in device development, but the results of an internal audit are not always easy to hear.

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