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About Eshraghi Medical Engineering Solutions

We're a consultancy dedicated to delivering expert support across the full lifecycle of medical devices, with a focus on orthopaedics and patient-specific technologies. Leveraging over fifteen years of industry experience, I support clients with: - Regulatory Strategy & Compliance: MDR/FDA/UKCA conformity, technical documentation, and notified body engagement. - Patient-Specific Devices: Expertise in custom-made cutting guides and implants, including design workflow optimisation and surgeon interface development. - Product Development & Engineering: Hands-on experience in CAD, 3D printing, anatomical modelling, and validation testing for Class II/III medical devices. - Quality Management Systems: Implementation and auditing of ISO 13485-compliant QMS frameworks. - Cross-functional Collaboration: Acting as a bridge between R&D, clinical users, regulatory affairs, and manufacturing teams. Whether supporting early-stage start-ups or established manufacturers, we provide tailored, practical solutions to accelerate innovation while maintaining the highest standards of safety and compliance.

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