How the AI Act, NIS 2, & Data Act will impact the EU medical devices regulatory landscape
Between August this year and September next year the regulatory environment in the EU regarding data will become more complex,…
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Design Control for Software | An introduction
The number of regulations, standards, and guidance documents specific to software in or as a medical device (SiMD, SaMD) is…
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A Regulatory Guide to Post-Market Surveillance
Post-Market Surveillance (PMS) according to MDR 2017/745 and IVDR 2017/746 is a systematic process to continuously monitor the safety and…
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Biocompatibility & Cleanliness Testing for Medical Devices
In the realm of medical technology and innovation, the development and production of safe and effective medical devices is of…
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Sorting the hype: The reality of AI application in medical devices
With extensive conversation and conjecture around Artificial Intelligence, it’s easy to lose sight of the technology’s true relevance to the…
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Quality Culture & Quality Transformation | Congenius Whitepaper
A successful business must constantly adapt to a changing environment. Markets, economic and political frameworks, technology – they permanently undergo…
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Rare Disease Clinical Trials | Challenges & Solutions
In the European Union, a rare disease is defined as one that affects no more than 1 person in 2,000,…
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How to streamline design transfer from manufacturer to supplier
Last year in our topical article How to optimize your supplier management, we examined the key issues, challenges, and opportunities…
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