NiTi medical components for OEM manufacturing
Quick Details:
Material: | Titanium wire, platinum wire, stainless steel wire, Platinum
iridium wire , Nickel titanium wire, gold wire |
processing range: | According to customer’s request |
Function: | For medical |
Certificate : | ISO 9001/ISO 13485 / ISO 14001 / OHSAS 18001 |
Description
Nickel-titanium alloy is a shape memory alloy,Memory alloy not only
has unique shape memory function, but also has excellent features
such as abrasion resistance, corrosion resistance, high damping and
super elasticity.
Nickel Titanium Alloy is the most important and most widely used in
shape memory metal alloy, because of its unique memory recovery
features, super elasticity, fatigue resistance, and
biocompatibility, so it has been applied to cruise too, the
people's livelihood, medical and other industries.
Quality Assurance
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
validation requirements.
Certificaton
•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