High Performance Micro Laser Welding With Marking / Etching Service

Product Specification

Laser marking etching service for OEM manufacture

Quick Details:

Description

We offer various laser manufacturing sloutions to meet medical devices requirements.

Laser marking can take on many forms - some applications specify highly visible, attractive marks, while others need marks on obscure places or small enough to be visible only using magnification - including annealing, bleaching, engraving, etching, and foaming.

The type of mark made is dependent on the characteristics of the laser used to make the mark. The energy density, wavelength, and material properties determine the type of interaction with the material.

High energy density and short wavelengths will typically yield ablative/material removal effects, while lower power density and longer wavelengths will typically yield thermal effects.

Competitive Advantage:

1. Thin wall welding,
2. non-contact process .
3. Similar and some dissimilar metallic materials welding.
4. Metallic and plastic materials marking
5. 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