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10K clean room can integrate senstive medical device solution for OEM manufacturing

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Good quality Medical Device Contract Assembly for sales
Good quality Medical Device Contract Assembly for sales
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10K clean room can integrate senstive medical device solution for OEM manufacturing

China 10K clean room can integrate senstive  medical device solution for OEM manufacturing supplier

Large Image :  10K clean room can integrate senstive medical device solution for OEM manufacturing

Product Details:

Place of Origin: CHINA
Brand Name: OEM

Payment & Shipping Terms:

Minimum Order Quantity: 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
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Detailed Product Description
Clean Room: Clean Room Medical Device Solution: Medical Device Solution
Processing Range: According To Customer’s Request Function: For Medical
Certification: ISO 14001 / OHSAS 18001 Environment: 10k Clean Room
High Light:

medical design and manufacturing

,

medical device solutions

 

 

10K clean room can integrate senstive  medical device solution 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

For > 0.5 microns particles can be as high as 99.99% of the intercepting efficiency, ensure the operation space of the federal standard 209 e (grade purification standard)

 

we develop custom-fit medical device solutions in 10K clean room, ensuring our clients maximum quality

at minimum cost. As a contract manufacturer, you benefit from dealing with Jenitek and can be confident of excellence at every stage of product development.

 

And our manufacturing process applies strict controls to deliver quality products on schedule.

 

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.

 

Certificaton

· 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

 

 

 

 

Contact Details
SU ZHOU JENITEK PRECISION DEVICE CO.,LTD.

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