Quality and Medical Device Packaging
ISO 13485, ISO 14644-1, FDA Registered
At Janco, commitment to quality medical manufacturing excellence is exemplified by our continued investment in our personnel, equipment, and facilities because 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. Providing an effective, well-defined path for product realization and process improvement beginning with data collection, analysis, the creation of new and/or revised process control documents, customer approval, and implementation. Our controlled document records are thoroughly maintained and secure 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. Ensuring that access to materials suitable for non-sterile, or sterile class I, II, III medical devices, packaging, and many other applications is never an obstacle. Allowing us to provide quick sourcing services and competitive project quotes.
Janco’s medical manufacturing division is certified to ISO 13485 and 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. While 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.