📄 Dossier Review, Formatting & Compilation – Medical Devices

Our Dossier Review, Formatting & Compilation service is designed to support medical device manufacturers in preparing fully compliant, submission-ready regulatory files for registration in the UAE, GCC countries, and Europe.

We ensure that your technical documentation meets the specific requirements of health authorities such as MoHAP (UAE), SFDA (Saudi Arabia), Qatar MoPH, and European Notified Bodies under EU MDR.

Our services include:

• Detailed review of medical device dossiers (technical, clinical, administrative content)
• Identification of gaps against applicable regulations (e.g., GHTF, EU MDR, GCC guidelines)
• Professional formatting of documentation according to local or international standards
• Full dossier compilation for electronic or hard copy submission (e.g., STED, CE marking files)

Whether you’re preparing a new device registration, renewal, or regulatory variation, we ensure your documentation is accurate, audit-ready, and fully aligned with the target authority’s expectations.

📋 Quality Management Systems (QMS)

Ensure full regulatory compliance with expert guidance on:

• Implementing ISO 13485-compliant QMS
• Conducting internal audits and risk assessments
• Supporting quality control (QC) and quality assurance (QA) operations
• Preparing documentation for QMS certification or audits