📄 Dossier Review, Formatting & Compilation – Medical Devices

We support medical device manufacturers in preparing high-quality, compliant documentation for regulatory submissions across the UAE, GCC, and Europe.
Our experts review and format all components of the Technical Documentation in line with local and international standards, such as EU MDR, MoHAP, and SFDA.

Our service includes:

• Comprehensive review of technical, clinical, and administrative sections
• Gap analysis to ensure alignment with current regulatory requirements
• Formatting according to specific authority templates (e.g., STED, CE files)
• Compilation of a submission-ready dossier in print or digital formats

📬 Dossier Submission & Follow-Up – Medical Devices

We manage the regulatory submission process from end to end, ensuring timely and accurate delivery of your medical device registration file to the appropriate authorities. Our team acts as your regulatory liaison, closely monitoring the submission status and promptly addressing authority requests.

Our service includes:

• Electronic or manual submission to health authorities (e.g., MoHAP, SFDA, CE Notified Bodies)
• Tracking and follow-up on submission progress
• Responding to authority queries and deficiency letters
• Coordination until final approval or licensing is obtained