interventional medical device in Clean Room Assembly for OEM manufacturing

interventional medical device in Clean Room Assembly for OEM manufacturing

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Description

Jenitek is equipped with a high class 10,000 cleanroom that is ideal for the assembly of your Class II & III medical devices.
 

Assembling medical device requires maximum efficiency, productivity, space.

We can help you with a total solution. We have an assembly process that is documented, controlled and fully validated based on your device. We understand that the assembly process is a critical step in the fabrication of your device and we'll involve you in each step of the setup process to make sure you're happy with your OEM products.

We have clean room-safe workstations for Class 10k environments, or tool storage and transport systems for machining areas, We has integrated solutions to meet your needs.

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

Certification

ISO 9001:2008 Certified

ISO 13485:2012 Certified

ISO 14001:2004 Certified

OHSAS 18001 Certified