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Medical Device Assembly for customized OEM manufacturing

Categories Medical Device 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
brand: OEM
material: Titanium,platinum,stainless steel
processing range: According to customer’s request
Packing and Tracing: Aseptic package
OEM assembly: yes
certification: ISO 9001/ISO 13485 / ISO 14001 / OHSAS 18001
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    Medical Device Assembly for customized OEM manufacturing

    Medical Device Assembly for customized OEM manufacturing


    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


    We can help you with a total solution. We have an assembly process that is documented, controlled and fully validated based on your device. We understand that the assembly process is a critical step in the fabrication of your device and we'll involve you in each step of the setup process to make sure you're happy with your OEM products.


    In a medical environment, the slightest product defect can expose stakeholders to potentially critical risks, be they patients, original equipment manufacturers, medical professionals or health care providers.To satisfy stringent safety regulations, it is essential that medical components perform precisely and consistently to product-specific requirements.


    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.


    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.


    Certificaton

    · ISO 9001:2008Certified
    · ISO 13485:2012Certified
    · ISO 14001:2004Certified
    · OHSAS 18001Certified
    ·

    Quality Medical Device Assembly  for customized OEM manufacturing for sale
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