CNC machining micro precision machining medical components for OEM manufacturing

Capabilities

Description

We supplies precision CNC machining services with a quick turn-around for high or low volume orders. our dedicated and skilled employees are backed by their many years of combined CNC machining experience. We are well-known for our innovation in medical components machining. Our experience and knowledge in the medical machining industry makes us ready for the manufacturing and machining of medical device, and precision components for other medical products.

Our CNC Swiss machining and micromachining allow us to create the most intricate medical device components and implants with accuracy, speed and cost-effectiveness.

Our process include: thread milling, thread whirling, broaching, drilling, reaming, tapping, boring, turning, milling, sawing, pointing, grinding, and bending.

Competitive Advantage:

1. Multiple spindle machining
2. High speed machining Smaller parts features
3. High precision machining.

Application:

Medical device, medical assemble device, medical equipment.

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 140001:2004 Certified

OHSAS 18001 Certified

FDA 21CFR 820 Certified

EU MDD 93/43 Certified

ISO 14971 2004 Certified