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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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  Understanding the UOUP (User Interface of Unknown Provenance) section of IEC 62366 -1:2015

  Comparison of the biggest unknown between IEC 62366:2007 and IEC 62366 -1:2015– Fig. 5.10 User Interface of Unknown Provenance (UOUP).

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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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  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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  An electrical engineer’s overview of IEC 60601-1 Scope and Normative References

  EE’s overview of IEC 60601-1 Scope and Normative References, one of the more important standards that apply during medical device development.

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  Five tips for managing innovation risk

  Risk management is a key element in your innovation process and an excellent skill. Here are five pro tips to managing innovation risk

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  3 ways to use failure to achieve project success

  Help guide client and team to achieve project success by considering potential pitfalls and mitigating project risks.

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