Quality & Regulatory

Quality Assurance

Janco Incorporated actively practices the principles of lean manufacturing and quality management, ensuring on-time delivery of products that meet exact specifications for total customer satisfaction.

Quality and Medical Device Packaging

ISO 13485, ISO 14644-1, FDA Registered

At Janco, our commitment to medical manufacturing excellence is exemplified by our continued investment in our personnel, equipment, and facilities. Central to the effectiveness of any quality system is a dedicated staff with up to date training and state of the art equipment.

Our quality management system is fully integrated into all aspects of Janco’s medical manufacturing division, sales, design, production, and customer support. We provide an effective, well-defined path for product realization and process improvement, including data collection, analysis, the creation of new and/or revised process control documents, customer approval, and implementation. We thoroughly maintain and secure our controlled document records because we understand the importance of confidentiality, accountability, and transparency to our customers.

Janco is a major foam distributor and has long-standing relationships with a large network of verified vendors of components, plastics, foam, and other materials. Access to materials suitable for non-sterile, or sterile class I, II, III medical devices, packaging, and many other applications is never an obstacle. This allows us to provide quick sourcing services and competitive project quotes.

Janco’s medical manufacturing division is certified to ISO 13485 standards and is FDA registered. Our ISO 14644-1 Class 7 and Class 8 certified cleanrooms are frequently monitored and tested to assure that they are kept well within their required operating parameters. All of our medical processes are regularly assessed and verified by thorough internal, independent, FDA, and Customer audits.

The medical device and packaging inspection staff at Janco perform meticulous validation testing according to ASTM, ISO, or custom standards, depending on your application. Janco Medical products offer complete traceability from individual product ID, back to raw material lot numbers.