On 16 October 2024, the Medical Device Coordination Group (MDCG) published the revised guidance titled “Application of MDR Requirements to […]
MedTech Regulatory Insights January 2025 Read More »
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Hello readers, we’re back with another topic in the series of Usability Engineering for Medical Device. The last blog described
How to write an intended use for a medical device? Read More »
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Usability engineering for medical devices, or human factors engineering, is a concept of understanding interactions between the user and the
Applying Usability Engineering to Medical Devices Read More »
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Cath Solutions Inc. recently got a CE mark and is keen to start selling. While trying to register with the
Do we need PMCF every time for every device? Read More »
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The previous blog on Make-in-India set an understanding for our readers about how the Indian medical devices market is growing,
Make-in-India forMedical Devices:Is there a support? Read More »
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Are you finding it overwhelming to maintain and keep track of your Quality Management System (QMS), ensuring compliance with regulatory
Advantages of an eQMS Software Read More »
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COMPLIANCE WITH ELECTRONIC IFUs – PRACTICAL GUIDE Read Now
COMPLIANCE WITH ELECTRONIC IFUs – PRACTICAL GUIDE Read More »
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STATISTICS 101: Normal distribution Read Now
STATISTICS 101: Normal distribution Read More »
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