Professional Plastic Micro Injection Molding for OEM manufacturing

Product Specification

Professional Plastic Micro Injection Molding for OEM manufacturing

Quick Details:

Description

specializes in the medical molding process from the beginning in the product development process through production with all necessary documentation. Molding for the medical industry involves critical processes that must offer repeatability, assurance of accuracy, and a high degree of quality. Micro Molding has the most effective protocol for validating the injection molding process for all of your medical molding needs.

For our plastic injection moldings, we use PA,PEEK,PC,LCP,PEI, PEBAX, , which offer excellent mechanical properties, high tensile strength to resist breakage, and high temperature load ratings to avoid deformation due to heat.to give the completed medical moldings mechanical advantages or other unique properties.

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 customer requirement.

And our manufacturing process applies strict controls to deliver quality products on schedule.

Competitive Advantage:

1. Design the mould according to customer’s requirement.
2. We can use Babyplast molding machine with innovated features.

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. Specifically configured to meet stringent packing validation requirements.

Certification

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