regulatory, scientific, and medical writing

High-quality regulatory documentation is essential — but internal resources are often limited, especially when deadlines are approaching.I specialize in regulatory, scientific, and medical writing for medical devices and IVDs, with a focus on post-market surveillance (PMS), clinical evaluation support, and literature-based documentation. I do not take on full regulatory projects; instead, I provide targeted support where it matters most—delivering well-structured, compliant documents that integrate seamlessly into your existing processes.

If your team needs expert support to complete critical documentation or accelerate progress, I can step in and help deliver.

About

I am Zsuzsanna Szvicsek, a molecular biologist holding a PhD in theoretical medicine, with specialised research expertise in tumour cell biology, offering professional regulatory writing services for medical devices and IVDs. While working in academia, I realised I was most driven by the impact of science beyond the laboratory—helping bring innovations closer to patients. With 4.5 years of experience in MDR-compliant medical device regulatory affairs, I transitioned into regulatory and medical writing, where I use my scientific background to deliver clear, evidence-based documents for medical devices and IVDs.For more detailed information about my professional background, please visit my LinkedIn profile.

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Based in Hungary, I support clients across Europe, providing regulatory, medcomm and scientific documents in both English and Hungarian.

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Let’s discuss your project needs — regulatory and medical writing services available in English and Hungarian.

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