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|Name:||Design And Development||Applications:||Hospitals|
medical device development,
medical equipment development
Process design and process development support for contract manufacturing
|Material:||Titanium,platinum,stainless steel, brass, plastics,|
|According to customer’s request|
|Certificate :||ISO 9001/ISO 13485 / ISO 14001 / OHSAS 18001|
The medical device market is a multi-billion dollar industry. Every engineered product for this sector, from scalpelsstents to complex medical equipment, must be designed and developed to approved procedures and standards.
We offers design support services and design for manufacturing for applications in the following areas:
Design Engineering Assistance
New product design and development
enables improved functional performance
Design For Manufacturing
Full-Service Product Design and development
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.
|· 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|