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  Understanding and preparing for MDSAP Medical Device Single Audit Program

  MDSAP Medical Device Single Audit Program audits will help ensure compliance with QMS and reduce the audit/inspection burden.

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  11 Lessons learned from medical device projects

  11 Lessons learned from medical device project implementations cover a range of topics from regulatory and quality to development.

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  Smoke and Mirrors – FDA Regulation of E-cigarettes

  Overview of FDA Regulation of E-cigarettes Deeming Tobacco Products to be subject to the Federal Food, Drug and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act.

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  Digital Health communication cost and deployability for medical devices 

  Digital Health communication technology cost and deployability for medical devices features a discussion of StarFish engineers

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  3 Implications for Medical Device Generated Data

  Implications of Device Generated Data using medical devices capable of data generation and uploading into digital health.

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  How to identify a Conformité Européenne mark vs a China Export mark

  How to identify a Conformité Européenne mark vs a China Export mark including meanings, regulations and visual layout of the two marks.

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  A design engineer’s perspective of medical device biocompatibility

  Design engineer’s perspective of medical device biocompatibility to help determine if a device needs to be biocompatible.

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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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