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@hammersmith19
Technical writer, Quality and Regulatory Consultant
Reino Unido
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Sobre mí
I facilitate your path to compliance; accelerate your device to market.
As a dedicated QA/RA Consultant with over 15 years of industry experience, I provide strategic compliance solutions to Clinical Research Organizations (CROs), Medical Device, IVD, and Digital Health software manufacturers. My goal is simple: facilitate timely, "right-first-time" approvals that drive business success.
My Expertise: I specialize in navigating complex regulatory landscapes, dealing directly with Notified Bodies and Competent Authorities to ensure your Technical Files and submissions are audit-ready.
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