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Precious Metal Sheet Medical Device Components With Validated Sterile Packing

Categories Medical Device Components
Place of Origin: CHINA
Brand Name: OEM
MOQ: 1
Price: discuss personally
Packaging Details: Aseptic package / Double package / Vacuum package
Delivery Time: According to contract request
Payment Terms: T/T
Supply Ability: According to products feature
name: medical components
material: Titanium,platinum,stainless steel, brass, plastics
OEM accept: Yes
brand: JENITEK
function: For medical
processing range: According to customer’s request
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Precious Metal Sheet Medical Device Components With Validated Sterile Packing

Precious metal sheet device converted into medical components


Quick Details:


Material:Titanium,platinum,stainless steel, brass, plastics,

processing range:

According to customer’s request
Function:For medical
Certificate :ISO 9001/ISO 13485 / ISO 14001 / OHSAS 18001

Description

The product consists of imaging catheters, surgical accessories and sterile bags. Accessories include flushing syringe, extension tube and three-way valve. It is expected to be used for ultrasonic examination of coronary arterial vascular lesions. Intravascular ultrasonography is used in patients who can undergo peritoneal coronary intervention.


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

· ISO 9001:2008Certified
· ISO 13485:2012Certified
· ISO 14001:2004Certified
· OHSAS 18001Certified
· FDA 21CFR 820In-Process
· EU MDD 93/43In-Process
· ISO 14971 2004Compliance
Cheap Precious Metal Sheet Medical Device Components With Validated Sterile Packing for sale
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