Lead Medical Writer
Pia is a Lead Medical Writer, producing high-quality regulatory documents and scientific communications for pharmaceutical and biotech clients.
6 articles
With the introduction of the Medical Device Regulation (MDR), the requirements for placing medical devices on the market have significantly increased. Additional manufacturers’ obligations concerning post-market surveillance (PMS), including post-market clinical follow-up (PMCF), have gained importance.
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Discover what is required to obtain and maintain marketing approval for Software Medical Devices in the EU.
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Over the past years, the QbD Group has amassed extensive experience in guiding manufacturers towards CE approval for their medical devices, now including compliance under MDR.
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Learn the various steps and required documents for conducting the State of the Art literature review for the clinical evaluation of your medical device.
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Although manufacturers will have more time to prepare their technical files for the MDR transition, it is wise not to delay implementation until the last minute. Learn how to plan MDR compliance for your medical device here.
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Explore the field of medical writing and the different types of medical writing projects in Healthcare. QbD Clinical is happy to help!
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