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10K Clean Room Sub Assembly Manufacturing , Medical Equipment Assembly

Categories Clean Room Assembly
Place of Origin: CHINA
Brand Name: OEM
MOQ: 1
Price: discuss personally
Packaging Details: Aseptic package / Double package / Vacuum package
Delivery Time: According to contract request
Payment Terms: T/T
Supply Ability: According to products feature
name: clean room assembly
applications: hospitals
OEM accept: Yes
brand: JENITEK
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    10K Clean Room Sub Assembly Manufacturing , Medical Equipment Assembly

    10K Clean Room Sub Assembly Manufacturing , Medical Equipment Assembly


    Quick Details:

    Material:Titanium,platinum,stainless steel, brass, plastics,

    processing range:

    According to customer’s request
    Function:For medical
    Certificate :ISO 9001/ISO 13485 / ISO 14001 / OHSAS 18001

    Description


    Our process capability in the 10K clean room, our medical device solutions, all of them are critical to guarantee perfect functionality. For products ranging from packaging and swabs to wound control and medical care, medical device must be safety. so production must meet the very highest of standards.


    To satisfy stringent safety regulations, it is essential that medical components perform precisely and consistently to product-specific requirements.


    In addition to factors such as tight tolerance, flow rates and wicking capabilities; cleanliness and aesthetics are of paramount importance.


    Quality Assurance

    Jenitek is committed to supplying products and services that meet the needs of customers, comply with statutory and regulatory requirements, increase customer satisfaction and maintain the effectiveness of the quality management systems through continuous improvement in products, processes and services.


    Jenitek's quality management system has been certified ISO 13485:2012 and ISO 9001:2008 in order to fulfill each of our customers' specific requirements. FDA's QSR 21 CFR PART 820 and EU MDD 93/42 EEC certifications are in process.


    We have a thorough quality system including four levels of documentation including manuals, procedures, work instructions and records. According to system documentation and processes, our quality activities such as production, inspection, product development (NPI), process validation, supplier chain control, and continuous improvement are controlled. This means we can deliver precision, performance and safety products and services to our customers around the world.


    6 Sigma Quality Team The Jenitek quality team understands these system standards are not only the foundation of quality management but also paramount to the importance of our medical products, customers and product development, production, and improvement process. We have extensive experience with quality management and use a range of methods and tools, including IQ/OQ/PQ, FMEA, PFMEA, and Design of Experiments (DoE) to support in product development and improvement processes.


    Packing and Tracing

    Products with validated sterile packing. Sealer and testing equipment specifically configured to meet stringent packing validation requirements.


    Certification

    ISO 9001:2008 Certified

    ISO 13485:2012 Certified

    ISO 14001:2004 Certified

    OHSAS 18001 Certified

    FDA 21CFR 820 In-Process

    EU MDD 93/43 In-Process

    ISO 14971 2004 Compliance


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