Customized Medical Device Assembly For Therapeutic Catheters Certificated
Quick Details:
| Material: |
Titanium,platinum,stainless steel, brass, plastics, |
processing range:
|
According to customer’s request |
| Function: |
For medical |
| Certificate : |
ISO 9001/ISO 13485 / ISO 14001 / OHSAS 18001 |
Description
The assembly of diagnostic and therapeutic catheters, micro-catheters and feed-throughs requires precision solder products that are made to tight tolerances and high quality standards.
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.
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.
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
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