Alloys Medical Device Parts , Metal Material Medical Equipment Components

Alloys medical device converted into medical components

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Description

This product is made of titanium alloy. After processing through CNC machining, the surface is cleaned, nickel plated, and gold plated after cleaning. Moreover, we have a complete product inspection and quality assurance system to ensure that the products fully meet customer requirements.

This product is a passive disposable biopsy forceps, the length of 160 cm, with and without needles two choices. The product has a clamping structure for a 2.0mm or larger tube endoscope.

The product is made of stainless steel pipe, sheath, sheath, needle, pliers, washer and handle.

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. Sealer and testing equipment specifically configured to meet stringent packing validation requirements.

Certificaton