Glen Feye is the President and Founder of Accurate Consultants has over 25 years of FDA consulting experience helping domestic and international clients overcome various FDA compliance challenges. He has assisted clients with FDA inspections and successfully mitigated over 25 Warning Letters.  Mr. Feye has also authored and managed numerous regulatory submissions for device, IVD, biologic, pharmaceutical, and combination products

Glen is an expert in quality systems.  He has help implement numerous efficient and effective quality management systems for various medical devices, IVD and pharmaceutical companies.

Some of Glen’s Areas of Expertise Include:

Design Controls and Risk Management- Biocompatibility and Sterilization

Complaint handling including post market surveillance remediation including MDR, and Corrections and Removals

QMS Auditor, development of quality system improvement plans to address system gaps and non-conformities