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  • Hitec Medical FDA training -FDA’s Definition of Medical Devices

    Hitec Medical FDA training -FDA’s Definition of Medical Devices FDA’s Definition of Medical Devices Medical devices refer to instruments, devices, tools, machinery, instruments, insertion tubes, in vitro reagents, or other related items that meet the following conditions, including co...
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  • Hitec Medical FDA training – Introduction to FDA regulations

    Hitec Medical FDA training – Introduction to FDA regulations Code of Federal Regulations (CFR) CFR is the integration of general and permanent rules published and published by federal government agencies and departments in the Federal Register, with universal applicability and legal effect...
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  • ARAB HEALTH

    From January 29 to February 1, 2024, the 49th Arab Health 2024 International Medical Equipment Exhibition was officially held at the Dubai World Trade Center. It is the largest international professional medical equipment exhibition in the Middle East, with a complete range of exhibits and good e...
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  • 2024 Arab Health

    Welcome to visit Hitec Medical at Hall 8 G38,  2024 Dubai Arab Health. Hitec is a professional manufacturer of Respiratory, Anesthesia, Urological and Infusion therapy products. Hitec is ISO13485 registered, US FDA listed, and to be MDR CE certified soon. Sincerely hope Hitec Medical will be one ...
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  • Hitec Medical MDR training – Technical documentation requirements under MDR(Part 2)

    Hitec Medical MDR training – Technical documentation requirements under MDR(Part 2) Clinical evaluation requirements under MDR Clinical evaluation:  Clinical evaluation is the collection, evaluation, and analysis of clinical data through a continuous and proactive approach, utilizing suf...
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  • Hitec Medical MDR training – Technical Documentation Requirements under MDR (Part 2)

    Hitec Medical MDR training – Technical Documentation Requirements under MDR (Part 2)   Clinical evaluation requirements under MDR Clinical evaluation: Clinical evaluation is the collection, evaluation, and analysis of clinical data through a continuous and proactive approach, utilizin...
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  • Hitec Medical MDR training – Technical Documentation Requirements under MDR (Part 1)

    Hitec Medical MDR training – Technical Documentation Requirements under MDR (Part 1) Elements Content Device description, included software and accessories General description of the product, including intended use and intended users; UDI; indications and contraindications; instruction...
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  • Hitec Medical MDR training – Product classification under MDR (Part 2)

    Hitec Medical MDR training – Product classification under MDR (Part 2) Rule 10. Diagnostic and testing equipment Equipment used for lighting (examination lamps, surgical microscopes) Class I; For imaging of radiopharmaceuticals in the body (gamma camera) or for direct diagnosis or detec...
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  • Hitec Medical MDR training – Product classification under MDR (Part 1)

    Product classification under MDR Based on the intended use of the product, it is divided into four risk levels: I, IIa, IIb, III (Class I can be subdivided into Is, Im, Ir, according to actual conditions; these three categories also require third-party certification before obtaining a CE certific...
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  • Hitec Medical MDR training -Definition of MDR Terms (Part 2)

    Hitec Medical MDR training -Definition of MDR Terms (Part 2)

    Hitec Medical MDR training -Definition of MDR Terms (Part 2)   Intend use The manufacturer designates the use in clinical evaluation based on the data provided in labels, instructions, promotional or sales materials, or statements.   Label Printed text or graphic information that appears o...
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  • Hitec Medical MDR training -Definition of MDR Terms

    Hitec Medical MDR training -Definition of MDR Terms

    Hitec Medical MDR training – Definition of MDR Terms Medical device It refers to any instrument, equipment, appliance, software, implant, reagent, material, or other item used solely or in combination by a manufacturer for one or more specific medical purposes in the human body: Diagnosis,...
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  • Hitec Medical training on MDR Regulation

    Hitec Medical training on MDR Regulation

    Hitec Medical training on MDR Regulation This week we conducted a training on MDR regulations.  Hitec Medical is applying for MDR CE certificate and estimate to get it next May. We learned about the development process of MDR regulations. On May 5, 2017, the Official Journal of the European Uni...
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