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Quality Systems Engineering (QSE) is organized to provide strategic and implementation services to the global medical device and diagnostics industry. Our business provides measurable quality systems and regulatory compliance solutions for virtually all of your business needs.

Services


We provide professional consulting support services to the medical device industry in the following areas.
  • Quality systems design, implementation, metrics, training, and support
  • Quality system and regulatory compliance management services
  • Certified quality engineering support; design and process validation and verification
  • Quality system auditing including QSIT audits, mock FDA audits, due diligence audits, and supplier audits
  • FDA inspection readiness - evaluation, preparation, and training
  • FDA enforcement activity remediation (Warning Letter, consent decree, etc.)
  • ISO and CE Mark certification and international product registration (EU)
  • Regulatory affairs strategy and support
  • Preparation and submission of pre-market submissions to FDA
  • New product development and business planning
  • CAPA system effectiveness improvements and metrics
  • Complaint and MDR system effectiveness and improvements
  • Risk Management process support
  • Quality system and regulatory compliance temporary management services
  • Training and mentoring

Our current and former client list of companies includes
  • Abbott Laboratories
  • Advanced Sterilization Products
  • Baxter International
  • Beckman-Coulter
  • Clinical Diagnostic Solutions
  • C.R. Bard, Inc.
  • Cordis Corporation
  • Dade Behring
  • Davol, Inc.
  • DePuy / Synthes
  • Ethicon
  • GE Healthcare
  • Invacare
  • Johnson & Johnson
  • Medtronic
  • Nipro Diabetes
  • Nipro Medical
  • Philips Healthcare
  • Siemens Medical Solutions
  • Zimmer, Inc.