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

Sebastian is Accurate Consultants Program Manager who plans and oversees design and development of multiple medical devices to market. Activities include regulatory strategy, planning, pre-production, production and post-market. Sebastian is also an acting Quality Manager to align all processes with 21 CFR 820 QSR’s and ISO 13485:2016 (QSMR).
He has developed Quality Management Systems for multiple firms in both hard copy and eQMS versions, implemented all major subsystems and ran Design Control and Risk Management implementation across multiple medical devices. Manages and assists clients to resolve various FDA Regulatory and Compliance issues, includes FDA 483 response and Warning Letter remediation projects to close-out. Also manage Device and Drug FDA Registration and Listings, handling Import and Export Compliance and remediation of Product hold issues.
He has successfully submitted many Medical Device Regulatory Filings including 513(g), Pre-Submissions, 510(k)’s, Pre-EUAs, and EUA’s.

510(k) Submissions submitted and cleared by FDA include:
o K250821 – 2025 – Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR)
o K242503 – 2025 – Trilly Oxygenator with Integrated Arterial Filter and Hardshell Reservoir
o K211209 – 2021 – Hycare International Nitrile and Latex Patient Examination Gloves
o K200977 – 2020 – Operating Room Innovations Inc. Modular Toga Submission

Dilip Ashtekar is a result oriented collaborative leader with over 39 years of successful proven record of handling increasing responsibilities in leading Pharmaceutical, Biotechnology, Cell therapy, and   Vaccine companies such as Intarcia Therapeutics, PAREXEL International, Gilead Sciences, Amgen Inc., AstraZeneca-MedImmune, Watson-Schein, Advance Tissue Sciences, Teva Pharma-Gensia Sicore, Chesapeake Biologics and CIBA‑GEIGY. Recognized as a proactive leader in anticipating, troubleshooting, resolving quality and regulatory issues, improving productivity and building high performance teams. 

An acknowledged industry expert in the following Areas

1. Microbiology, aseptic processing, contamination control programs, visible particle control for parenteral products and Devices, visual Inspection processes for parenteral drugs, compliance audits and building quality culture.

2. Data Integrity compliance and sterility assurance for the aseptic manufacturing of drug substance and sterile drug product (small molecules, therapeutic monoclonal antibody vaccines and proteins).

3.Extensive experience with sterile Medical Devices Combination Products.

4. Aseptic manufacturing facility validation conventional ISO5 cleanroom, Isolators and RABS.

A member of USP Council for Expert Microbiology Committee (2010-present) and serving as a key member of several PDA Task forces and key author Technical reports; Environmental Monitoring TR 13, Mycoplasma Clearance by Filtration and Rapid Microbiology Methods, TR 33) and Key expert of ISPE Microbiological Data Integrity Task force.

Dr. Mario Gennari is an experienced regulatory and quality based professional, working in the Medical Device, In-Vitro Diagnostic and Pharmaceutical Industries for over twenty years. His core expertise is in the Regulatory Requirements and Quality Management System, including Design Control, Process validation, Tests Methods Validation, Management experience in sterilization technologies and their validations clinical investigations/evaluation, PMCF in compliance with MDCG, ICH GCP and FDA guidelines and audits at sites of investigational products, clinical analysis labs. In addition, he has specific expertise in R&D and quality requirements for Medical Devices, Diagnostics and Combination products. This has included the writing, implementation and maintenance of Quality systems, auditing of external suppliers and manufacturing/distribution sites and due diligence auditing. He also has extensive experience in the application of Design Control and post market surveillance systems for Complaints Management and Vigilance Reporting, Process Validation, CAPA, risk management and Clinical studies.

Location: Modena – Italy