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|Name:||Clean Room Assembly||Integrated Solution:||Integrated Solution|
|Processing Range:||According To Customer’s Request||Function:||For Medical|
|Certification:||ISO 9001/ISO 13485 / ISO 14001 / OHSAS 18001||Material:||Titanium,platinum,stainless Steel, Brass, Plastics|
Customized interventional Medical Device Assembly for OEM manufacturing
|Material:||Titanium,platinum,stainless steel, brass, plastics,|
|processing range:||According to customer’s request|
|Certificate :||ISO 9001/ISO 13485 / ISO 14001 / OHSAS 18001|
Jenitek is equipped with a high class 10,000 cleanroom that is ideal for the assembly of your Class II & III medical devices.Super clean workbench crystallization environment for the samples, the filtered positive pressure laminar unfiltered downdrafts can prevent outside air into the cab, positive pressure laminar air flow can prevent cross pollution, indoor sample operation of energy-saving overhead type variable air volume air supply system, with high performance, long life, high efficiency air filter.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.
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.
|· 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|