Micro molding plastics for OEM medical device manufature

Quick Details:

Description

Overmolding involves two or more materials molded together to become one part. High part precision achieved by leading edge molding equipment, capable tooling, and robust validation procedures Shot-to-shot consistency guaranteed by instrumented moldsSignificant reduction or elimination of costly and cumbersome assembly operations that can lead to failure modes and high fall-out ratesSome micro projects require specialty micro injection molding processes, such as overmolding.

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. 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. Specifically configured to meet stringent packing validation requirements.

Certification

ISO 9001:2008 Certified

ISO 13485:2012 Certified

ISO 14001:2004 Certified

OHSAS 18001 Certified

FDA 21CFR 820 In-Process

EU MDD 93/43 In-Process

ISO 14971 2004 Compliance