10K environments to sub-assembly for medical device in clean room
|Material:||Titanium,platinum,stainless steel, brass, plastics,|
|processing range:||According to customer’s request|
|Certificate :||ISO 9001/ISO 13485 / ISO 14001 / OHSAS 18001|
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
To satisfy stringent safety regulations, it is essential that
medical components perform precisely and consistently to
In addition to factors such as tight tolerance, flow rates and
wicking capabilities; cleanliness and aesthetics are of paramount
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.
For medical device solutions, durability, workmanship and
cushioning are critical to guarantee perfect functionality.
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
|· ISO 9001:2008||Certified|
|· ISO 13485:2012||Certified|
|· ISO 14001:2004||Certified|
|· OHSAS 18001||Certified|