20+ years MedTech experience
Contact This ExpertJoelle Faught
Fractional Quality & Regulatory Expert
MIS Fractional
Specialties
Joelle Faught is a fractional quality and regulatory expert with over 20 years of medical device industry experience. She provides hands-on support for quality system development, regulatory submissions, and compliance programs for early-stage through established medical device companies.
Services Offered
Quality System Development
FDA and ISO 13485 quality management system development and implementation.
Regulatory Affairs
FDA 510(k), De Novo, and PMA regulatory strategy and submission preparation.
Design Controls
Design history file development and design control process implementation.
Supplier Quality
Supplier qualification, audits, and quality agreements.
Work With Joelle
Available for short-term virtual fractional consulting engagements. No long-term commitments required.
Contact an Expert