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  6 benefits of FDA Breakthrough Devices program

  6 benefits mean the FDA program for breakthrough medical devices may be your best regulatory option for novel medical devices.

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  Is the FDA Early Feasibility Studies Program right for you?

  FDA's Early Feasibility Studies Program (EFS) is a great option in early stage development looking to advance your program by gathering data.

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  Navigating Medical Device International Regulations

  Proper research and communication with authorities in each country of interest will make Medical Device International Regulations smoother to navigate.

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  Medical Devices and GDPR (the EU General Data Protection Regulation)

  GDPR is designed to enhance the privacy and security of data subjects.  Medical devices and GDPR cross paths in many areas.

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  Qualifying and Managing RoHS and REACH suppliers

  RoHS and REACH are two regulations that requires compliance if a company intends to sell in the European Union.

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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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  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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  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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