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FDA & EU MDR Biocompatibility Expectations Introduction Biocompatibility is a core requirement for medical device approvals across global markets. Among all regulatory authorities, the US Food and Drug Administration (FDA) and the European Union Medical Device Regulation (EU MDR) are...
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Biological Evaluation Report (BER) Expectations Introduction The Biological Evaluation Report (BER) is one of the most critical documents in a medical device regulatory submission. While the Biological Evaluation Plan (BEP) explains what will be done, the BER demonstrates what was...
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Biological Evaluation Plan (BEP) Explained Introduction A Biological Evaluation Plan (BEP) is one of the most important documents in the biocompatibility assessment of a medical device. Regulatory authorities such as the US FDA and EU Notified Bodies expect a clear,...
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Impact of ISO 10993-1:2025 on Global Approvals Introduction Global approval of medical devices depends heavily on how well manufacturers demonstrate biocompatibility and patient safety. Regulatory authorities such as the US FDA, EU Notified Bodies and other international agencies rely on...
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ISO 10993:2025 vs 2018 – Key Differences Introduction The ISO 10993 series is the global benchmark for evaluating the biocompatibility of medical devices. Among its parts, ISO 10993-1 plays a central role by defining the overall framework for biological evaluation....
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What’s New in ISO 10993-1:2025 for Medical Devices Introduction Biocompatibility is a critical requirement for every medical device that comes in contact with the human body. Regulators across the world rely on the ISO 10993 series to evaluate whether a...
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Microbiological Testing for Medical Devices Microbiological Testing for Medical Devices: Ensuring Safety, Sterility and Regulatory Compliance Medical devices come into contact with patients in hospitals, clinics, homes and laboratories. Many devices are invasive, implanted or used during critical procedures. Because...
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Clinical Evaluation Reports (CER) Clinical Evaluation Reports (CER): The Backbone of Medical Device Compliance Clinical Evaluation Reports, commonly known as CERs, have become one of the most crucial requirements for medical device approval across global markets. Under regulations such as...
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Packaging & Mechanical Testing Packaging and Mechanical Testing for Medical Devices: Ensuring Safety, Sterility and Global Compliance Medical devices are highly sensitive products. They must stay sterile, protected and fully intact from the moment they are manufactured until they reach...
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Stability & Transportation Testing Stability and Transportation Testing for Medical Devices Medical devices must remain safe, effective and reliable throughout their entire shelf life and during transportation. Whether the device is stored for months or shipped across cities, countries or...
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