Customized Medical Device Clean Room Assembly In 10K Environment OEM manufacturing

Customized Medical Device Clean Room Assembly In 10K Environment OEM manufacturing

Quick Details:

Description

For products ranging from packaging and swabs to wound control and medical care, medical device must be safety. so production must meet the very highest of standards.

For medical device solutions, durability, workmanship and cushioning are critical to guarantee perfect functionality.

In a medical environment, the slightest product defect can expose stakeholders to potentially critical risks, be they patients, original equipment manufacturers, medical professionals or health care providers.

In addition to factors such as tight tolerance, flow rates and wicking capabilities; cleanliness and aesthetics are of paramount importance.

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 Aseptic package / Double packing / Vacuum package. Specifically configured to meet stringent packing validation requirements.

Certificaton