Seeking FDA Consultant for Digital Thermometer

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We are looking for an experienced FDA consultant to assist with the regulatory process for our Digital Thermometer, a simple and reliable device for accurate temperature measurement. Scope of Work -Regulatory Strategy: Determine the appropriate FDA pathway and ensure compliance with applicable regulations. -Documentation & Submission: Prepare and submit technical documentation, including device description, intended use, and performance data. -Labeling Compliance: Ensure FDA-compliant labeling under 21 CFR Part 801. -Quality Management System (QMS): Verify compliance with 21 CFR Part 820 and ISO 13485. -Post-Market Compliance: Develop a basic post-market surveillance plan. What We Need -Experience with FDA submissions for medical devices, particularly simple diagnostic devices. -Knowledge of 21 CFR Part 820, ISO 13485, and labeling requirements. -Ability to handle regulatory inquiries and provide follow-up support. Deliverables -Regulatory pathway determination. -FDA-compliant technical documentation. -Corrected and approved product labeling. -Post-market surveillance plan. -Ongoing support for FDA inquiries.

Keyword: Digital Marketing

Price: $50.0

Regulatory Compliance Regulatory Intelligence Quality Assurance Quality Management System Quality Control Quality Audit