Packaging Details | Aseptic package / Double package / Vacuum package |
Payment Terms | T/T |
Delivery Time | According to contract request |
Supply Ability | According to products feature |
brand | JENITEK |
name | Clean Room Assembly |
feature | Visual Process Controls |
advantage | Continuous Manufacturing |
application | medical device |
environment | clean room |
Brand Name | OEM |
Place of Origin | CHINA |
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Product Specification
Packaging Details | Aseptic package / Double package / Vacuum package | Payment Terms | T/T |
Delivery Time | According to contract request | Supply Ability | According to products feature |
brand | JENITEK | name | Clean Room Assembly |
feature | Visual Process Controls | advantage | Continuous Manufacturing |
application | medical device | environment | clean room |
Brand Name | OEM | Place of Origin | CHINA |
High Light | medical parts manufacturing ,medical device solutions |
interventional medical device in Clean Room 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
Jenitek is equipped with a high class 10,000 cleanroom that is ideal for the assembly of your Class II & III medical devices.
Assembling medical device requires maximum efficiency, productivity, space.
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 happy with your OEM products.
We have clean room-safe workstations for Class 10k environments, or tool storage and transport systems for machining areas, We has integrated solutions to meet your needs.
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 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
Company Details
Business Type:
Manufacturer,Distributor/Wholesaler,Importer,Exporter,Seller,Other
Year Established:
2010
Employee Number:
100~120
Ecer Certification:
Active Member
Jenitek established in 2010, it is located in Medical Device Industrial Park of Suzhou New District and is a professional contract manufacturer for medical devices. Based on our capability of assembling various types of micro-medical devices and processing parts and components, we provide ... Jenitek established in 2010, it is located in Medical Device Industrial Park of Suzhou New District and is a professional contract manufacturer for medical devices. Based on our capability of assembling various types of micro-medical devices and processing parts and components, we provide ...
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