Questions? Please call 603-742-1581
FDA Registered
 ISO 13485

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, IS0 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 clean rooms 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.

FDA Janco Info

Establishment:

Janco, Inc.

50 Goodwin Rd

Rollinsford, NH

03869

Registration Number:

3010060157

Registration Status:

Active

Owner/Operator:

Janco, Inc.

Broadway Ext.

P.O. Box 857

Dover, NH 03821

Owner/Operator Number:

10043068

Official Correspondent:

Barbara D Grimes

Broadway Ext.

P.O. Box 857

Dover, NH 03821

Phone: 603-742-1581

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© 2017 Janco Inc., 50 Goodwin Road, Rollinsford, NH 03869

Phone: 603-742-1581 | Fax: 603-749-0082 | Solutions@janco-inc.com

Janco, Inc. Medical Division