Integrated Manufacturing Medical Device Contract Assembly With OEM Service

Integrated manufacturing in interventional implantable medical devices

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Description

For medical equipment suppliers, To satisfy stringent safety regulations, it is essential that medical components perform precisely and consistently to product-specific requirements.

As a qualified supplier , you benefit from dealing with a single supplier and can be confident of excellence at every stage of product development. From needs analysis through prototyping and testing to after-sales services.

Our medical device assembly solution to meet virtually any requirements, giving you access to cutting-edge designs and materials.

we develop custom-fit medical device solutions in 10K clean room, ensuring our clients maximum quality at minimum cost. As a contract manufacturer, you benefit from dealing with Jenitek and can be confident of excellence at every stage of product development.

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. 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