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OEM Medical Device Micro Plastic Injection , Medical Injection Molding

SU ZHOU JENITEK PRECISION DEVICE CO.,LTD.

OEM Medical Device Micro Plastic Injection , Medical Injection Molding

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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 : micro molding

material : plastic

applications : hospitals

OEM accept : Yes

function : medical

size : according to customer's request

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Micro molding plastics for OEM medical device manufature

Quick Details:

Max melting temperrature: 420
Min thickness : 0.08mm
Min injection volume: 0.1mm3.
Processing range: Insert molding, over-molding, Thin-wall molding
Tooling size: 200 x 200mm
Clean room grade 10k, 100K
Application materials: PA,PEEK,PC,LCP,PEI, PI,PEBAX

Description

Micro molding parts requires specialized micro-processing, baking, warming, upper tooling, molding,, as well as post-processing and inspection methods. And we can use Babyplast manchine to molding machine with innovated features. Some parts are so small the only way to implement processing is to use special post-processing technology and non-contact measuring methods to inspect them.

Suzhou Jenitek currently manufactures products for interventional and implantable devices. and includes a Class 100,000 Clean Room, with capabilities up to class 10,000, and certified Class 100 Laminar Flow Hoods. Our implement processing is to use special post-processing technology and non-contact measuring methods to inspect them. Regular audits and factory inspections by CSA ensure our quality system operates at the level of performance required to consistently produce high quality Often times our micro machined parts reach the smallest limit and we hold tolerances to meet customer requirement.

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

Competitive Advantage:

  1. Design the mould according to customer’s requirement.
  2. We can use Babyplast molding machine with innovated features.

Application:

Electro physiology test and radio frequency ablation to treat dead heart tissue

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. 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:

thin wall injection molding

      

medical injection molding

      
China OEM Medical Device Micro Plastic Injection , Medical Injection Molding wholesale

OEM Medical Device Micro Plastic Injection , Medical Injection Molding Images

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