Medical Device Compliance Services
Enabling Compliance. Supporting Market Access. Ensuring Patient Safety.
Yashfin provides end-to-end regulatory and quality consulting services for medical device manufacturers across the product lifecycle. Our solutions are designed to meet global and local regulatory requirements while supporting efficient market access, sustained compliance, and long-term operational scalability.
We support organizations across design, registration, post-market surveillance, quality systems, and inspection readiness, helping medical device companies confidently navigate evolving regulatory landscapes.
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Medical Device Regulatory Strategy & Market Access
- Regulatory strategy for new device registrations and market entry
- Device classification and regulatory pathway assessment
- Gap analysis against applicable regulations and standards
- Market access planning across multiple regions
- Lifecycle regulatory planning and change impact assessment
02
Technical Documentation & Submissions
- Preparation and review of Technical Documentation / Design Dossiers
- GSPR / Essential Requirements mapping
- Risk management file support (ISO 14971 aligned)
- Clinical and performance evaluation support
- Submission support for new registrations, variations, and renewals
03
Quality Management System (QMS) for Medical Devices
- ISO 13485–aligned QMS design and implementation
- SOP development for design, manufacturing, and post-market activities
- Document control, CAPA, deviation, and change control systems
- Risk-based quality management integration
- Support for scalable, multi-site device operations
04
Post-Market Surveillance & Vigilance
- Post-Market Surveillance (PMS) system design and implementation
- PMS Plans and PMS Reports preparation
- Trend analysis and signal identification
- Medical device vigilance and incident management
- FSCA coordination and regulatory communication support
Our Services
Contact Us
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B04-332, Business Center 03, RAKEZ Business Zone-FZ,
Ras Al Khaimah, UAE - +971 55 895 5849
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info@yashfin.net
info@yashfinpharma.com
Our Brochures
Explore our Service Prospectus for a clear, easy-to-read overview of all services we offer.