20+ years MedTech experience
Contact This ExpertKatrina Fiedler
Lead Consultant, Regulatory, Quality & Compliance
WolfKat Regulatory Consulting, LLC
Specialties
Katrina Fiedler, founder of WolfKat Regulatory Consulting, LLC, is a regulatory, quality, and compliance expert with over 20 years in the medical device industry. She provides comprehensive regulatory strategy and QMS support for both domestic and international regulatory submissions.
Services Offered
FDA Regulatory Strategy
510(k), De Novo, and PMA pathway selection and submission preparation.
EU MDR Compliance
Technical documentation and Notified Body submissions for EU market access.
Quality Management Systems
ISO 13485-compliant QMS design, implementation, and maintenance.
Post-Market Surveillance
PMS planning, MDR/MDV reporting, and complaint handling systems.
Work With Katrina
Available for short-term virtual fractional consulting engagements. No long-term commitments required.
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