Contract Services

Contract Design and Manufacturing Services

Konigsberg Instruments, Inc. is a custom, make-to-order Medical Device Manufacturer. We design and manufacture proprietary products, and provide design and sub-contract manufacturing services for other device manufacturers and distributors. We design products that are used in a medically regulated environment, either in clinical diagnostic settings or in regulated pharmaceutical trials, as well as those used in unregulated studies or for research purposes.

We can design subassemblies or complete systems, applications specific test equipment for manufacturing or field test and simulation, and create complete document and training packages.

Customers have the option of choosing programs that will be designed or manufactured with documentation and traceability that meets full regulatory requirements (FDA and ISO CE/MDD), or you may choose reduced requirements for one-of-a-kind, non-medical or experimental projects.

Services to Medical and other Original Equipment Manufacturers

  Private Label Design and Manufacturing

  Subcontract Manufacturing

  Sensor Design

  Application Specific, NIST Traceable, Test Equipment Design

  Electronics Design & Packaging


Full Regulatory Compliance Available

  Licensed Medical Device Manufacturer - California # 30471

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

  ISO CE/MDD Compliance - ISO 13485    0470

  Safety & Training Programs

  Certified In-Process, Test and Manufacturing Equipment

  Established Engineering Design Control System