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.
Latest Blog posts
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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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How can you take advantage of China’s accelerated regulatory pathways for your product development?
Global drug innovation in the East has significantly increased in recent years. China is one of the major players and…
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The EU Regulatory Framework for Microbiota Transplants: An Industry Perspective
The current European regulatory framework for Blood Tissue and Cells is being replaced by a new Regulation, which includes a…
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Key Points in the CTR Transition of Clinical Trials
Are you an innovator with a product undergoing clinical trial? This article covers all you need to know about the…
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