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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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  Tips to Avoid Medical Device AI Pitfalls

  Exploration of the potential in using Medical Device AI with tips on how to avoid pitfalls in AI implementation.

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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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  How to Perform Medical Device Drop Test

  Outlines how medical device designers can perform in-house Medical Device Drop Test per IEC 60601-1 before third party testing.

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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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  Medical Device Design for the Developing World

  Medical Device Design for the Developing World – why are there so many nonfunctional and broken medical devices in low-income regions?

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