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|Name:||Clean Room Assembly||Applications:||Hospitals|
medical design and manufacturing,
medical device solutions
10K clean room assemble medical device subassembly for OEM manufacturing
|Material:||Titanium,platinum,stainless steel, brass, plastics,|
|According to customer’s request|
|Certificate :||ISO 9001/ISO 13485 / ISO 14001 / OHSAS 18001|
Our process capability in the 10K clean room, our medical device solutions, all of them are critical to guarantee perfect functionality. For products ranging from packaging and swabs to wound control and medical care, medical device must be safety. so production must meet the very highest of standards.
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.
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