プロフィール詳細

プロジェクトを作成

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☆☆☆☆☆

Karissa T.に依頼

United States

Your Partner in Regulatory Success | 17+ Yrs | 510(k), EU MDR, IVDR | Expert Support Within Your Budget

プロフィール概要

I’m a seasoned Regulatory Affairs Consultant with over 17 years of experience supporting medical device and IVD companies in achieving global compliance and successful submissions. My expertise spans FDA 510(k) submissions, EU MDR and IVDR technical documentation, and global market registrations. I specialize in submission readiness reviews, ensuring documentation meets the latest regulatory requirements for safety, performance, and quality. I offer detailed quality checks of regulatory documentation, assess change controls for ongoing compliance, and provide SOP gap analyses and updates aligned with evolving FDA, ISO 13485, and international standards. Whether you are preparing an initial submission, responding to regulatory queries, or remediating existing files, I bring precision, efficiency, and clarity to the process. If you're new to the market or in early development, I can help you understand the minimum regulatory requirements for your product and guide your team in preparing the foundational elements needed before proceeding with a formal submission. My support helps early-stage companies avoid costly missteps and align strategically with long-term regulatory goals. I work with both startups and established companies, offering flexible, budget-conscious solutions without compromising on compliance or quality—ensuring you get expert-level support at a cost that works for your business. Clients rely on me to outline global regulatory pathways, identify gaps, and support both pre-submission planning and final dossier reviews. I tailor my services to fit the needs of startups, midsize manufacturers, and global organizations—delivering timely, compliance-driven results.

専門分野

• ★ Medical Device Regulatory Consulting
• ★ European Medical Device Regulation (MDR)
• ★ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ☆ Medical Devices
• ☆ ISO 13485
• ☆ ISO 14971

サービス

• Writing
• Research
• Consulting
• Product Development

Writing Clinical Trial Documentation, Non-Medical Regulatory Writing, General Proofreading & Editing

Research Gap Analysis

Consulting Go-to-Market Strategy Consulting, Regulatory Consulting

Product Development Product Compliance

職務経験

Consultant/Owner

MD Regulatory Consulting Inc.

3月 2020 - 現在

Regulatory Consultant

NAMSA

1月 2015 - 3月 2020

学歴

Masters Regulatory Science

St Cloud University

1月 2011 - 8月 2014

B.Sc. Biology

University California San Diego

8月 2005 - 7月 2008

認定資格

• NA

  NA

  1月 2025 - 1月 2025