ENQUAL LLC Business Brief
MDR 2017/745, 21 CFR 820, QSR ISO 13485, ISO 14971, ICH Q8, Q9, Q10 and cGMP
Provides guidance in the medical device / combination (pharmaceutical) products arena for New Product Development and Quality Management Systems optimization. Utilization of a blend of mechanical and quality engineering skills with consideration of risk and regulatory compliance throughout the product realization process.
Services
Verification and Validation
EU MDR strategies and compliance
Systems Engineering
Design Control
Design of Experiments
Root Cause Analysis
Purified Water System Assessment
Statistical Analysis
Products and Device Types
- Central Venous Catheter
- Parenteral Drug Delivery
- Ultrasonic Surgical Instruments
- IVD clinical chemistry
- Orthopaedic implants
- 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)