Custom Medical Packaging
Industrial Plastic Fabrication
Call: 603.742.1581
|solutions@janco-inc.com|
Quality Control
ISO 9001 and ISO 13485 Registrations
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.
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