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  17 Lessons learned from 3 FDA inspection strategies and results

  Highlights of lessons learned from 3 FDA inspection strategies and visits to medical device manufacturer and clients.

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  FDA inspection results from 3 different preparation strategies

  FDA inspection outcomes from 3 very different inspection preparation strategies with lessons learned from the inspections.

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  Medical applications and early stage design – silicone material selection

  The two key variables in rapid silicone prototyping are silicone material selection and moulding strategy.

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  4 ways to make your jig design process more effective

  4 ways (with related principles) to make your medical device jig design process more effective. Jigs help us conduct tests and collect data.

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  7 Benefits of Using Adaptive Design for Clinical Studies

  Adaptive studies can be especially useful in the pivotal stage if there are uncertainties about one or two aspects of the study.

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  Will new FDA final rule on symbols for device labels make devices cheaper?

  FDA final rule on symbols is an important step towards global medical device harmonization and hopefully for a decrease in manufacturing costs as well.

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  How ISO 13485:2016 changes will impact your QMS (sections 4-6)

  Review of sections 4, 5 and 6 of ISO 13485:2016 and the major changes from the 2003 version with potential impacts on QMS.

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  3 real–world approaches to an FDA inspection

  FDA inspection of our Quality Management System (QMS) and 2 medical devices that are contracted to StarFish Medical manufacturing.

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  IEC 62366-1:2015 vs Applying Human Factors and Usability Engineering

  Exploration of applying IEC-62366-1:2015 or human factors engineering to the design of medical devices compared to the FDA guidance document.

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