Customized Medical Device Sub-Assembly for contract manufaturing
|Material:||Titanium,platinum,stainless steel, brass, plastics,|
|According to customer’s request|
|Certificate :||ISO 9001/ISO 13485 / ISO 14001 / OHSAS 18001|
The assembly of medical devices (such as catheters, guide wires,
Nitinol,stents, etc.) uses a wide variety of alternative assembly
processes that require non-standard assembly products.
Suzhou Jenitek currently manufactures products for interventional
and implantable devices.
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