We advise biomedical technology clients in start-up business development as well as re-engineering of established businesses, quality assurance systems and compliance, regulatory strategies and submissions, clinical trial design and management, and operations development. This also includes regulatory and quality support for companies with FDA or other regulatory compliance difficulties. Auditing, systems development support, and certification are routine but focused, customized activities.

Our management consulting activities are focused in the following areas. To learn more about how MedQ Systems can add value to your business, click on any of the listed items.

Clinical and Medical Affairs
Regulatory Strategies, Submissions and Compliances
Product Development
Operations Development
Process Validation and Performance Improvement
Quality Assurance

We also conduct focused problem-solving, improvement assistance, or project management in such technical areas as:
  • Product Quality Improvement
  • Regulatory submission preparation
  • Biocompatibility assessment
  • Sterilization and biological QA programs
  • Controlled environment and utilities design and validation
  • Documentation systems and change controls
  • Design verification and validation, including hardware and software
  • Product design and development processes
  • FDA/ISO quality system audits and compliance
  • Supply chain definition and development
  • Supplier evaluations and quality system audits
  • Manufacturing process development
  • Manufacturing process validation
  • Manufacturing systems and performance
  • Capital equipment service and repair systems

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