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I will design your fda clinical study protocol and endpoint strategy

B
bengreen927
B
bengreen927
Ben G
design your fda clinical study protocol and endpoint strategy
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design your fda clinical study protocol and endpoint strategy

About this gig

Are you developing a medical device that requires clinical evidence for FDA submission? I provide expert clinical study design and protocol development services tailored to your regulatory pathway.


What You Get:


  • SR/NSR (Significant Risk / Non-Significant Risk) determination for your device
  • - Complete study design with appropriate control groups and randomization strategy
  • - Primary and secondary endpoint selection aligned with FDA guidance documents
  • - Patient population definition with inclusion/exclusion criteria
  • - Sample size justification using validated biostatistical methods
  • - Statistical Analysis Plan (SAP) overview
  • - Regulatory timeline mapping for IDE submission readiness

Why Work With Me:


I specialize in FDA medical device clinical study design under 21 CFR 812 (IDE regulations). My protocols are developed to meet CDRH expectations, reducing the risk of clinical holds or deficiency letters. Whether you need a focused feasibility study or a full pivotal trial protocol, I deliver clear, submission-ready documentation.


All deliverables are provided in Wor

Get to know Ben G

Ben G

FDA regulatory writer and ISO 13485 QMS specialist for medical devices

  • FromUnited States
  • Member sinceJan 2022

  • Languages

    English, Portuguese
Medical device regulatory and quality systems specialist with hands-on experience across ISO 13485, 21 CFR 820/QMSR, EU MDR, and FDA submissions. I write SOPs, quality manuals, risk management files (ISO 14971), DHFs, and regulatory submission packages — delivered on time and audit-ready. My background spans startups to established device companies, covering design controls, CAPA, process validation, supplier management, and post-market surveillance. BSI ISO 13485 certified. Fluent in English and Portuguese.