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• CASE STUDY 1: Quality System for Medical Devices Groups within Global Pharmaceutical Company
  Implementation of a Quality Management System to comply with the requirements of EN ISO 13485:2003, MDD Annex II and the FDA Quality System Regulation. Key Activities included:
  
  • Gap analysis
  • Process mapping
  • Creation of new QMS Manual and SOPs for major processes
  • Review and update of all QMS documentation
  • Staff training
  
  
  
• CASE STUDY 2: Regulatory Affairs and Project Management of UK/US Product Development
  Advised on the regulatory strategy for CE Marking and FDA market clearance and project managed the product development of a complex electromechanical diabetes monitoring device for US client. Key Activities included:
  
  • MDD Device Classification and Essential Requirements Analysis and creation of Technical File
  • EN 60601 Safety Assessment
  • Assistance with FDA 510(k) Premarket notification
  • Project Management of product design and development, Design Verification and Validation planning and implementation
  • Sterile package validation