Stainless Steel Tig Micro Laser Welding For Medical Parts ISO Certification

Micro Tig welding service for OEM manufacturing

Quick Details:

Description

Micro TIG welding (micro tungsten inert gas),  is an arc welding process that uses a non-consumable tungsten electrode to produce an arc which creates the weld. Micro TIG welding is a non-contact process, which, like laser welding, requires an external fixture to apply force to create proper part fit up. It utilizes a constant current welding power supply which produces high quality welds with minimal heat affected zone by generating arcs between the workpiece and the tungsten electrode, and using the resultant heat to create the joint.

Micro TIG processes focus on welding small parts of area 5 mm x 5 mm. These are usually delicate parts in the automotive, medical, or electronics industry. Pulsed arc welding has many advantages. For example, it’s a solder-free process and the resultant weld is highly durable when exposed to vibration and heat. In addition, pulsed micro TIG welding is widely applicable for joining high melting point metals, dissimilar metals, and even thin magnet wires of φ0.02mm. The weld area is generally protected from atmospheric contamination by use of an inert shielding or cover gas (argon or helium).

Competitive Advantage:

1. The weld area is generally protected from atmospheric contamination by use of an inert shielding or cover gas (argon or helium). pulsed micro TIG welding is widely applicable for joining high melting point metals, dissimilar metals, and even thin magnet wires of φ0.02mm. .
2. high quality welds with minimal heat affected zone

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