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  Creativity, Collaborations and Culture from the Lens of a Systems Engineer

  Systems engineering can enable creativity and nurture a collaborative development culture for Medical Device Creative Collaborations.

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  When Tolerance Studies Add Value in Medical Device Development

  Examples of how to apply tolerance studies that add value to medical device design and ultimately to biomedical start-ups.

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  Reducing Costs in Medical Device Verification and Validation

  How to identify hidden costs in medical device Verification & Validation along with mitigation measures to reduce the expense. 

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  Regulatory Science Tools Reduce Risk in New Medical Devices

  How the FDA Catalog of Regulatory Science Tools can reduce risk in medical devices and explores several tools and categories.

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  Medical Device NPI & Commercialization Lessons Learned

  Medical Device New Product Introduction (NPI) & Commercialization lessons for medical device strategy, design, development, and NPI success.

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  Cleanroom Validation Testing for Medical Device Manufacturing

  Overview of Cleanroom Validation Testing for Medical Device Manufacturing Cleanrooms based upon actual Toronto facility experience.

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  Regulatory Checklist

  The intent of this checklist is to aid self-assessment of your medical device commercialization readiness relating to regulatory requirements. Compare the answers you provide with stages from the StarFish Product Development Process at the end of the checklist to identify how ready you are for applicable regulatory requirements.

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  US Reimbursement Codes for Medical Devices

  The main success criteria for medical device companies after earning FDA regulatory clearance is securing positive coverage decisions from payers. While regulatory approval is sufficient to get a product to market, it has no bearing on product adoption. The availability of reimbursement has a direct impact on therapy adoption – it can “make or break” a product1. This primer provides an overview of US reimbursement codes and when they are used to help determine coverage and payment for medical devices.

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  Designing BLDC motor drive electronics

  Designing BLDC motor drive electronics focuses on the particular strategy of driving the motor windings with sinusoidal waveforms.

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