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Contact Shellie K.

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Profile Details

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USD 100 /hr

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Hire Shellie K.

United States

USD 100 /hr

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

Profile Summary

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.

Subject Matter Expertise

Services

Writing

Writing Medical Writing

Work Experience

Founder and Principal Medical Writer

BLAZSMed Scribe Consulting LLC

April 2025 - Present

Lead Medical Writer

W.L. Gore & Associates

July 2020 - April 2025

Clinical application specialist

W.L. Gore & Associates

April 2018 - June 2020

Education

PhD Biomedical Engineering

University of Arizona

August 2011 - May 2018

BS in Chemical Engineering

University of Arizona

August 2008 - May 2011

Certifications

Certification details not provided.