Medical Device Endoscope Precision Laser Cutting OEM Manufacturing

Product Specification

Medical device endoscope laser cutting capability for OEM manufacturing

Description

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.

The Laser micro machining process is a multi pass process that removes small layers and volume of the material on each pass. Typically the laser is moved at high speeds over the stationary part, going over the cut path many times to achieve the feature. This is analogous with any machining operation in general, however the layer thickness removed can be in the microns and tenths of thousandths of an inch providing very high dimensional accuracy. For ultra fast or ultra short pulse lasers, almost any material can be processed, particularly plastics and polymers, which are difficult to machine accurately when feature and part size dimensions are small.

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. 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