Cardiovascular component laser cutting mature capability

Description

Our solutions meet a diverse set of market needs across a variety of categories including cardiovascular components. Laser cutting and laser micro machining are non-contact processes which utilize a laser for micro drilling, micro milling, micro machining, micro patterning and ablation for industrial applications. The cut and feature edges are of high quality with little no burring, low surface roughness and dimensional accuracy.

Competitive Advantage:

1. Centripetal cutting & vertical cutting,
2. Burr-free and high precision cutting
3. Many secondary manufacturing processes are provided to shorten supply chain and reduce procurenment costs & cycles, such as machining, insert molding, surface treatment.

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.

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