Implantable Devices Clean Room Assembly Customized Processing Range

Implantable Devices Clean Room Assembly Customized Processing Range

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Description

Suzhou Jenitek currently manufactures products for interventional and implantable devices. and includes a Class 100,000 Clean Room, with capabilities up to class 10,000, and certified Class 100 Laminar Flow Hoods.

Our implement processing is to use special post-processing technology and non-contact measuring methods to inspect them. Regular audits and factory inspections by CSA ensure our quality system operates at the level of performance required to consistently produce high quality Often times our micro machined parts reach the smallest limit and we hold tolerances to meet customer requirement.

And our manufacturing process applies strict controls to deliver quality products on schedule.

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 Aseptic package / Double packing / Vacuum package. Specifically configured to meet stringent packing validation requirements

Certificaton

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.