ENQUAL LLC Business Brief
MDR 2017/745, 21 CFR 820, QSR ISO 13485, ISO 14971, ICH Q8, Q9, Q10 and cGMP
ENQUAL provides senior-level quality, regulatory, and engineering support to medical device, combination product, and pharmaceutical organizations operating under regulatory scrutiny. We support leadership teams across product development, manufacturing, and quality systems by translating regulatory requirements into defensible decisions, inspection-ready documentation, and durable system improvements aligned with FDA, ISO, EU MDR, and cGMP expectations.
ENQUAL’s role is to help organizations demonstrate control, clarity, and accountability across their quality systems in a manner that withstands regulatory scrutiny.
Consulting Services
Warning Letter Response
Verification and Validation
EU MDR strategies
Risk Management
Systems Engineering
Design Control
Design of Experiments
Root Cause Analysis
Purified Water System Assessment
Statistical Analysis
Products and Device Experience
- Central Venous Catheter
- Parenteral Drug Delivery
- Ultrasonic Surgical Instruments
- IVD clinical chemistry
- Orthopaedic implants and instruments
- Automated immunohematology analyzer
- Electro-mechanical-fluidic devices
- Extracorporeal photopheresis
- Tangential Fluid Flow Cassettes
- Nylon pleated filters
- Purified water systems (USP water for injection and USP purified water)