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  How to handle changes under the 21st Century Cures Act and device exemption list

  How to handle recent medical product development regulatory changes under the 21st Century Cures Act and device exemption list.

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  Areas to consider when preparing for MDR 2017/745

  Start early to avoid surprises when preparing for MDR 2017/745. The new EU medical device regulations will come into full force in Q2 2020.

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  5 Tips to effectively manage competence and training

  Tips to manage competence and training, keep up to date and ensure personnel are trained and competent to perform their duties.

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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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  CE vs China Export Mark Explained – Avoid Costly Mistakes

  CE vs China Export Mark Explained – Discover meanings, regulations and visual layout of the two marks to avoid costly mistakes.

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