CORE CONSULTING SERVICES

QFI has extensive insight and business know-how in the medical devices regulatory field, particularly for CE marking and FDA clearance. Using our expertise, we secure national and international regulatory assurance and compliance for your medical devices. Through our consulting service, QFI provides your medical device with:

CE Marking

We implement the CE mark by:

• Classifying your device
• Selecting the appropriate Notified Body
• Communicating with the appropriate Competent Authority
• Preparing your Technical Documentation
• Producing a Product Design Dossier
• Conducting Hazard Evaluations
• Project managing your clinical investigations
• Speeding up your application

FDA Clearance

We gain FDA clearance by:

• Classifying your device
• Registering your establishment and your device
• Preparing and submitting your 510(k)
• Obtaining Premarket Approval
• Completing a Product Development Protocol
• Securing Investigational Device Exemption approval
• Conducting Hazard Evaluations

Quality Management System

Our Quality Management Systems:

• Satisfy US FDA, Health Canada, EU regulations and TGA for Australia
• Allow legal market placement
• Comply with QSR, ISO 9001 and ISO 13485