WE HELP MEDICAL DEVICE COMPANIES GET TO MARKET FASTER & ACHIEVE TRUE QUALITY

realize  products to market without delays and high costs
realize  products to market without delays and high costs
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    • Article of the week
    • Business Brief
    • Experience
    • Expertise
    • Employee Portal

  • Home
  • Article of the week
  • Business Brief
  • Experience
  • Expertise
  • Employee Portal

ENQUAL LLC Business Brief

MDR 2017/745, 21 CFR 820, QSR ISO 13485, ISO 14971, ICH Q8, Q9, Q10 and cGMP

ENQUAL provides guidance in the medical device / combination (pharmaceutical) products arena for New Product Development and Quality Management Systems optimization. We support team leadership using a blend of mechanical and quality engineering services with consideration of risk and regulatory compliance throughout the product realization process.

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)

Contact Us

Better yet, meet us in person!

Enqual

devin.mack@enqual.us (585) 360-9184

Copyright © 2018 - 2021 Enqual LLC - All Rights Reserved.

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