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SU ZHOU JENITEK PRECISION DEVICE CO.,LTD.
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10K Clean Room Sub Assembly Manufacturing , Medical Equipment Assembly

SU ZHOU JENITEK PRECISION DEVICE CO.,LTD.

10K Clean Room Sub Assembly Manufacturing , Medical Equipment 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

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


Product Tags:

medical design and manufacturing

      

medical device solutions

      
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