Mature medical micro molding contract manufacturer

Quick Details:

Description

Suzhou Jenitek is solely committed to providing the highest quality micromolding services of advanced medical products. Jenitek offers their innovative skills in producing very small, delicate, and intricate components required for advanced medical applications and products such as specialized surgeries, bioabsorbable devices, and implant devices. Products with micro-sized features can exist on the surface of miniature and micro-sized parts, as well as be produced in abundance by using micromolding. Micromolding technology is effective, repeatable, durable, and cost effective for many production applications

Medical micro injection molding requires much more specialized equipment than traditional micro injection molding. In the medical device world, it’s often the smallest parts that carry the greatest importance relative to the functionality and safety of a medical device. More than ever, embracing the best proven processes and tools for manufacturing is critical to successful product development.With advanced micro injection molding, it is possible to achieve successful validated production of complex components in a variety of medical grade plastics.

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

Competitive Advantage:

1. Design the mould according to customer’s requirement.
2. We can use Babyplast molding machine with innovated features.
3. Insert injection: including plastic bag plastic and plastic bag metal.

Application:

Electro physiology test and radio frequency ablation to treat dead heart tissue.

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. Specifically configured to meet stringent packing validation requirements.

Certification

ISO 9001:2008 Certified

ISO 13485:2012 Certified

ISO 14001:2004 Certified

OHSAS 18001 Certified