Peace, mercy, and blessings of God be upon you 🌷 I am Eng. Consultant for medical devices and supplies and regulation of medical products. I offer integrated consulting services for factories and companies in the field of medical devices and supplies, including: 🔹 Review and prepare MDMA files Review the product technical file. Review Device Description / BOM / Label & IFU. Review Risk Management according to ISO 14971. Review Verification & Validation files according to the nature of the product. Review PMS and product-related documents. Identify deficiencies and prepare the file in the appropriate format for submission. 🔹 ISO 13485 – QMS Prepare and review the ISO 13485 Quality Management System for medical devices and supplies. Prepare and review the Quality Manual. Prepare and review Procedures & Work Instructions. Prepare system-specific Forms & Records. Align the quality system with the nature of the company's activity and products. Review the facility's readiness for audit and obtaining ISO 13485 certification. Support the client in addressing observations and non-conformities resulting from the audit. 🔹 Registration on Ghadd platform Registration of medical devices and supplies. Prepare and enter product data. Upload required documents and files. Follow up on the request and observations received from the authority. Prepare responses and required documents until the request procedures are completed. 🔹 The service includes: ✅ Medical Devices ✅ Medical Supplies ✅ MDMA Files ✅ QMS Quality System ✅ ISO 13485 ✅ Registration and follow-up via Ghadd platform