Quality Assurance System

Quality Systems at Konigsberg Instruments

The management and staff at Konigsberg Instruments, Inc. are committed to providing products and services of the highest quality. Konigsberg Instruments, Inc. is a custom, make-to-order Medical Device Manufacturer that designs and manufactures proprietary regulated products, and provides sub-contract manufacturing and design services for other medical device manufacturers. Our products are typically used in a medically regulated environment, either in clinical diagnostic settings or in regulated pharmaceutical trials.

In order to make our products available worldwide, our quality system has been designed to meet the requirements of the United States Food and Drug Administration (FDA), and ISO 13485:2003 and /Medical Device Directives. While all of our products are manufactured under the same Quality Assurance program, the FDA and ISO inspectors audit only the clinical sub-contract manufacturing services and our GI Motility and pH Probes.

In order to make our products available worldwide, our quality system has been designed to meet the requirements of the United States Food and Drug Administration (FDA), and ISO 13485:2003 and CE/Medical Device Directives. While all of our products are manufactured under the same Quality Assurance program, the FDA and ISO inspectors audit only the clinical sub-contract manufacturing services and our GI Motility and pH Probes.

Regulatory Compliance Certifications

Licensed Medical Device Manufacturer - California #30471Licensed Medical Device Manufacturer - California #30471

Konigsberg Instruments, Inc. is licensed in the State of California as a Medical Device Manufacturer

U.S. Food & Drug Administration Registration #2020337U.S. Food & Drug Administration Registration #2020337

Konigsberg Instruments, Inc. Quality System meets U.S. FDA Good Manufacturing Practices (GMP) and Quality System Requirements (QSR)

ISO /MDD Compliance - ISO 13485:2003 0470ISO CE/MDD Compliance - ISO 13485:2003 CE 0470

Our proprietary GI Motility Probe designs are /MDD Registered Worldwide.  ISO 13485:2003 is the Medical Device Manufacturers' standard for ISO compliance. There are a number of elements in the ISO 9000 standard that are incompatible with FDA Quality System and /MDD Requirements. Our proprietary GI Motility Probe designs are CE/MDD Registered Worldwide.  ISO 13485:2003 is the Medical Device Manufacturers' standard for ISO compliance. There are a number of elements in the ISO 9000 standard that are incompatible with FDA Quality System and CE/MDD Requirements.

NIST Traceable Test Equipment and SystemsNIST Traceable Test Equipment and Systems

FDA Good Manufacturing Practices and Quality System Requirements and ISO 13485:2003 require that process and test equipment be regularly tested and certified to published, recognized standards that are traceable to those maintained by the National Institutes of Standards and Technology.

Konigsberg Instruments Compliance Mechanisms

Safety and TrainingSafety and Training

All processes and procedures are thoroughly documented. New employees receive extensive on the job training. They are carefully monitored before receiving written certification that they have exceeded required skill levels. In addition to regular supervision, certified employees are evaluated and re-certified on a regular schedule.

In-Process test and Manufacturing Equipment

We maintain an extensive list of production, inspection and test equipment. The equipment is tested and calibrated on an established schedule. This ensures that the equipment meets published specifications, in accordance with reference standards traceable to those established by the National Institutes of Standards and Technology.

Engineering Design Controls

Konigsberg Instruments offers complete engineering services that are compliant with FDA Quality System Requirements and ISO /Medical Device Directives. We can provide a complete paper trail, and take your regulated product from concept to market.

KONIGSBERG INSTRUMENTS, INC.
2000 East Foothill Blvd.    Pasadena, CA  91107
Phone: (626) 449-0016    Fax: (626) 449-1086
Email: kiinfo@konigsberginc.com

2000 East Foothill Blvd.     Pasadena, CA  91107     
Telephone 626.449.0016     Fax  626.449.1086     
kiinfo@konigsberginc.com