Micro molding plastics for OEM medical device manufature
|Max melting temperrature:||420℃|
|Min thickness :||0.08mm|
|Min injection volume:||0.1mm3.|
|Processing range:||Insert molding, over-molding, Thin-wall molding|
|Tooling size:||200 x 200mm|
|Clean room grade||10k, 100K|
|Application materials:||PA,PEEK,PC,LCP,PEI, PI,PEBAX|
Micro molding parts requires specialized micro-processing, baking,
warming, upper tooling, molding,, as well as post-processing and
inspection methods. And we can use Babyplast manchine to molding
machine with innovated features. Some parts are so small the only
way to implement processing is to use special post-processing
technology and non-contact measuring methods to inspect them.
Suzhou Jenitek currently manufactures products for interventional
and implantable devices. and includes a Class 100,000 Clean Room,
with capabilities up to class 10,000, and certified Class 100
Laminar Flow Hoods. Our implement processing is to use special
post-processing technology and non-contact measuring methods to
inspect them. Regular audits and factory inspections by CSA ensure
our quality system operates at the level of performance required to
consistently produce high quality Often times our micro machined
parts reach the smallest limit and we hold tolerances to meet
And our manufacturing process applies strict controls to deliver
quality products on schedule.
- Design the mould according to customer’s requirement.
- We can use Babyplast molding machine with innovated features.
Electro physiology test and radio frequency ablation to treat dead
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. Specifically configured to
meet stringent packing validation requirements.
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