Stainless Steel Micro Resistance Welding Service For Medical Device Parts

Micro resistance welding service for OEM manufacturing

Description

Resistance welding is a thermo-electric process in which heat is generated at the interface of the parts to be joined by passing an electrical current through the parts for a precisely controlled time and under a controlled pressure (force). The name “resistance” welding derives from the fact that the resistance of the workpieces and electrodes are used in combination or contrast to generate heat at their interface.

Core resistance welding technologies include Linear DC, High Frequency Inverter, Capacitive Discharge and AC.

Resistance spot welding, seam welding, gap welding, projection welding, thermo compression bonding, strand welding and insulated wire welding. Four key parameters influence the quality of resistance welding and need to be closely monitored to achieve best in class results: materials, energy, weld force and time.

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

Jenitek established in 2010, it is located in Medical Device Industrial Park of Suzhou New District and is a professional contract manufacturer for medical devices. Based on our capability of assembling various types of micro-medical devices and processing parts and components, we provide supporting and overall assembly services for vascular intervention and active implantable devices.

Jenitek is a fast growing company. It now has internationally advanced level manufacturing capabilities. Suzhou Jenitek is market-oriented, and continuously improves the company's core competitiveness. After a few short years, we have micro-machining, micro-spot welding, micro-wire

processing, microinjection molding, surface treatment of miniature parts and other micro manufacturing capabilities, and have gradually formed the complete flow from parts manufacturing to assembly of micro devices. Suzhou Jenitek is ISO certified (ISO13485, ISO9001, ISO14001) and OHSH18001 systems certified and is currently obtaining certification of U.S. FDA QSR 820 and EU MDD 93/42/ECC systems. The company has a quality management team identified by ASQ Six Sigma Master Black Belt and Green Belt and was awarded the "Achievement of Value Improvement Process" by an internationally renowned medical device company.

Jenitek has an outstanding product development team. We apply DFMEA, DOE, IQ/OQ/PQ and excel at changing small and complicated operations into controllable and measurable simple actions through creative processes and tooling design. Innovation and development are the common goals of all members

of Jenitek. The company creates an atmosphere of innovation with product development, Six Sigma continuous improvement, comprehensive proposals and other innovative platforms to achieve common development of the enterprise and employees.

Jenitek is committed to being a leader of the contract manufacturing industry for medical devices. We take advantage of advanced manufacturing technologies to help customers to bring new products to market quickly for beneficial results.