With over 20 years of expertise in the Design and Manufacturing of Medical Devices specially in Ophthalmology field, Implementation of Quality Management system (ISO 13485), Also Product Standards, and creating precise Technical Files to meet European regulatory requirementsKnowledge of European requirements of Medical Devices including:- EN ISO 14971: Medical devices-Application of risk management to medical devices- EN 60601-1: General requirements for basic safety and essential performance - EN 60601-1-2: General requirements for basic safety and essential performance -Electromagnetic compatibility- IEC 60601-2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories- IEC 60601-1-6: General requirements for basic safety and essential performance - Usability- EN 62366 : Application of usability engineering to medical devices- EN 62304: Medical device software — Software life-cycle processes- EN ISO 14155:Clinical investigation of medical devices for human subjects- EN 1041:Information supplied by the manufacturer of medical devices- EN ISO 15223-1: Medical devices-Symbols to be used with information to be supplied by the manufacturer- ISO 60529: Degrees of protection provided by enclosures (IP Code)
Rubimed
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Co-Founder And CtoRubimed Nov 2019 - PresentRichmond Hill, Ontario, Canada
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Biomedical EngineerAalipayam Medical Engineering Co. 2000 - 2023Tehran, Tehran Province, Iran• Over a decade specializing in designing, production and technical services of medical devices, particularly surgical and diagnostic equipment in ophthalmology.• Expert in the design of mechanical components and systems, and medical devices which obtained regarding to designing and production 7 models of Phaco-Vitrectomy machines and related accessories• Expertise and in-depth knowledge of fundamental and details operation of phaco-vitrectomy machines.• Extensive experience in installation, calibration, maintenance, and repair of medical devices.• Valuable expertise in supporting product development from conceptual stage to design, prototyping, and production.• Proficient in implementing of medical device risk management and FMEA aligned with the ISO 14971 standard.• In-depth knowledge of Quality Management System (QMS) according to ISO 13485 standard
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Mechanical Design EngineerPayedar Jahan Company 1999 - 2000
Mostafa Iranmanesh Education Details
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Biomedical Engineering-Biomechanics -
First Rank Student
Frequently Asked Questions about Mostafa Iranmanesh
What company does Mostafa Iranmanesh work for?
Mostafa Iranmanesh works for Rubimed
What is Mostafa Iranmanesh's role at the current company?
Mostafa Iranmanesh's current role is Senior Biomedical Engineer/Medical Equipment Design, Production, quality control/Medical device regulations and quality management system.
What schools did Mostafa Iranmanesh attend?
Mostafa Iranmanesh attended Iran University Of Science And Technology, Shahid Bahonar University Of Kerman.
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