The dedicated staff at Janco, Inc. actively practices the principles of total quality management which integrates all organizational functions toward innovation, continuous quality improvement and total customer satisfaction. Operating in a controlled, clean room environment is vital element of medical manufacturing. Janco, Inc.’s commitment to quality medical manufacturing excellence is exemplified by our ISO 9001 and ISO 13485 registrations with emphasis on monitored batch control and material traceability. Our streamlined processes and customer-focused approach to quality improvement maximize the cost-efficiency, performance and utility of your custom manufactured medical products.

ISO 14644-1 Certifications
ISO 9001-2008 Certifications
ISO 13485-2003

• In-line Cleanroom Certification-Class 8
• Shuttle Cleanroom Certification-Class 8
• Packaging Cleanroom Certification-Class 7
• ISO 9001-2008 Certification
• ISO 13485 Certification

Quality and Medical Device Packaging

Seal Strength Equipment F100-2600-3

GMP: The scope of Janco, Inc.’s registered Quality Management System (QMS) is further enhanced by Good Manufacturing Practice or GMP (also referred to as “cGMP” or “current Good Manufacturing Practice”) - a term that is recognized world-wide to ensure that your medical device packaging and medical packaging product are manufactured and held in a state of control, thereby contributing to the safety, effectiveness and consistency of your medical application.

The GMP culture at Janco, Inc. intertwines operational methods, required validations, and process controls with effective, disciplined documentation practices to ensure that your custom-manufactured medical product and medical packaging specifications have been met and monitored for lot traceability and labeling integrity, with the appropriate records retention to enable on-going support of your customized medical device packaging and medical manufacturing needs.

Environmental Health & Safety Manager
Bill Frattini
bill.frattini@janco-inc.com