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Interventional Medical Device Assembly for OEM Manufacturing

SU ZHOU JENITEK PRECISION DEVICE CO.,LTD.

Interventional Medical Device Assembly for OEM Manufacturing

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Brand Name : OEM

Certification : ISO 9001/ISO 13485 / ISO 14001 / OHSAS 18001

Place of Origin : China

MOQ : 1

Payment Terms : T/T

Delivery Time : according to contract request

Packaging Details : Aseptic package / Double package / Vacuum package

name : medical device assembly

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

function : for medical

application : for hospitals

OEM accept : Yes

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Interventional Medical Device Assembly for 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

Assembling electronic and mechanical parts requires maximum efficiency, productivity, space.

vascular interventional technique device need strict requirenments. 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 setisfied with your OEM products.

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 Aseptic package / Double packing / Vacuum package. Specifically configured to meet stringent packing validation requirements.

Certification

ISO 9001:2008 Certified

ISO 13485:2012 Certified

ISO 14001:2004 Certified

OHSAS 18001 Certified


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