We like to keep our readers up to date on complex regulatory issues, the latest industry trends and updated guidelines to help you to solve a problem or make an informed decision.
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Digital Health Series – Part 3: Software as a Medical Device Regulated by the EU
Previously, we talked about how the FDA regulates Software as Medical Device (SaMD), in this blog post we will discuss…
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The regulatory challenge for determining status between medical devices and cosmetic products with borderline claims…
In the Part 1 of the blog post, we explored the regulations relating to medical devices and cosmetic products in…
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FDA Meeting Series: How, When and What – INTERACT Meetings
INTERACT Meetings What: CDER is now also accepting INTERACT Meetings. Initial Targeted Engagement for Regulatory Advice on CBER/CDER Products (INTERACT)…
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The regulatory challenge for determining status between medical devices and cosmetic products with borderline claims…
In the competitive race for innovation and marketing, a manufacturer may develop new technological products with the objective of using…
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Digital Health Series – Part 2: Software as a Medical Device Regulated by the US…
Artificial Intelligence has achieved major milestones in the US, with the FDA granting clearance to the first AI-based software for…
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Selection of a Notified Body for Medical Device Development
In the European Union (EU) the review and approval of medical devices and in vitro diagnostic medical devices often requires…
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Digital Health Series – Part 1: Defining Software as a Medical Device
Recently, the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has provided updates to the guidance Software and AI…
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Importance of Quality Management Review for Medical Devices
If you are an innovator developing a device, it is critical to understand the purpose and innerworkings of quality management…
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