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High Precision Medical Device Contract Assembly For Hospital ISO Certification

Certification
Good quality Medical Device Contract Assembly for sales
Good quality Medical Device Contract Assembly for sales
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High Precision Medical Device Contract Assembly For Hospital ISO Certification

China High Precision Medical Device Contract Assembly For Hospital ISO Certification supplier
High Precision Medical Device Contract Assembly For Hospital ISO Certification supplier High Precision Medical Device Contract Assembly For Hospital ISO Certification supplier

Large Image :  High Precision Medical Device Contract Assembly For Hospital ISO Certification

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
Name: Medical Device Contract Assembly Applications: Hospitals
OEM Accept: Yes Brand: JENITEK
Processing Range: According To Customer’s Request Function: For Medical
High Light:

contract manufacturing assembly

,

sub assembly manufacturing

Medical device contract assembly in 10K clean room 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 medical equipment suppliers, To satisfy stringent safety regulations, it is essential that medical components perform precisely and consistently to product-specific requirements.

 

Smaller components in smaller 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.

 

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.

 

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

 

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

Contact Person: admin

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