Integrated manufacturing in interventional implantable medical
|Material:||Titanium,platinum,stainless steel, brass, plastics,|
|processing range:||According to customer’s request|
|Certificate :||ISO 9001/ISO 13485 / ISO 14001 / OHSAS 18001|
For medical equipment suppliers, To satisfy stringent safety
regulations, it is essential that medical components perform
precisely and consistently to product-specific requirements.
As a qualified supplier , you benefit from dealing with a single
supplier and can be confident of excellence at every stage of
product development. From needs analysis through prototyping and
testing to after-sales services.
Our medical device assembly solution to meet virtually any
requirements, giving you access to cutting-edge designs and
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.
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. 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. 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|
|· FDA 21CFR 820||In-Process|
|· EU MDD 93/43||In-Process|
|· ISO 14971 2004||Compliance|