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Ask the Experts: Unleashing the potential: Unveiling the regulatory drivers of the SaMD market in the US and EU
Software as a medical device (SaMD) has been used in the healthcare sector for many years, particularly in the space of imaging and treatment planning. At the same time, the…
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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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Ask the Experts: MHRA’s Innovative Licensing and Access Pathway (ILAP)
In its new role of an independent regulator, the UK’s MHRA regulatory agency is emerging as a flexible and welcoming…
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Navigating the FDA Draft Guidance Document “Manufacturing Changes and Comparability for Human Cellular and Gene…
In the ever-evolving landscape of pharmaceuticals/biopharmaceuticals, manufacturing changes play a pivotal role in ensuring the quality and effectiveness of medicinal…
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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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Ask the Experts: Unleashing the potential: Unveiling the regulatory drivers of the SaMD market in…
Software as a medical device (SaMD) has been used in the healthcare sector for many years, particularly in the space…
blog
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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Ask the Experts: How to use microbiome as an innovative diagnostic tool
Over the past decade, innovations in both sequencing technology and computational biology have led to a growing interest in profiling…
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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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Key CMC and NC considerations for cell and gene therapy development
ATMPs (Advanced Therapeutic Medicinal Products) in Europe, or CGTs (Cell and Gene Therapies) as they are known in the US,…
