📄 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 and Europe.

We ensure that your technical documentation meets the specific requirements of health authorities such as MoHAP & EDE (UAE),

Our services include:

• Detailed review of medical device dossiers (technical, clinical, administrative content)
• Identification of gaps against applicable regulations (e.g., GHTF, EU MDR, UAE guidelines)
• Professional formatting of documentation according to local or international standards

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
• Preparing documentation for QMS certification or audits