プロフィール詳細

プロジェクトを作成

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Shellie K.に依頼

United States

EU MDR Clinical Evaluation Specialist | CER, CEP, PMCF for Class IIb/III Implantable Devices

プロフィール概要

Manufacturers turn to me when their Notified Body has flagged a Clinical Evaluation Report, or when their clinical evidence strategy can't withstand scrutiny under MDR xxxxxxxx. I'm a biomedical engineering PhD with direct manufacturer-side experience at W.L. Gore & Associates, where I worked inside the regulatory and clinical evidence process for Class IIb/III implantable devices, not from the outside looking in. I now run an independent practice focused on the documents that decide whether a device stays on the EU market: Clinical Evaluation Reports, Clinical Evaluation Plans, PMCF Plans and Reports, SSCPs, and the literature reviews that support them. What I deliver: CER/CEP development and rewrites that anticipate Notified Body objections before they're raised PMCF Plans and Reports aligned to your device's actual risk profile, not a generic template Literature reviews structured to MEDDEV 2.7/1 Rev 4 and current MDCG guidance Gap assessments that tell you exactly what's missing, with a cited source, not a vague checklist. If your team doesn't need (or can't yet justify) a full-time regulatory hire, I step in for the document that's due now, without the overhead of a retained consultancy.

専門分野

• ☆ Medical Devices
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)

サービス

• Writing

Writing Medical Writing

職務経験

Founder and Principal Medical Writer

BLAZSMed Scribe Consulting LLC

4月 2025 - 現在

Lead Medical Writer

W.L. Gore & Associates

7月 2020 - 4月 2025

Clinical application specialist

W.L. Gore & Associates

4月 2018 - 6月 2020

学歴

PhD Biomedical Engineering

University of Arizona

8月 2011 - 5月 2018

BS in Chemical Engineering

University of Arizona

8月 2008 - 5月 2011

認定資格

• 認定資格の詳細は未入力です。