Geneva Laboratories

1001 Proctor Drive, P.O. Box 140
Elkhorn, WI 53121

About Geneva Laboratories

Geneva Laboratories, Inc. provides the medical device industry with personalized quality service to meet cGMP/GLP requirements. Geneva Labs’ 22,000 sq. ft. facility houses laboratories to accommodate testing capabilities for Chemistry analysis, Microbiology, and Biocompatibility, including six ISO Class 5 (Class 100) clean rooms. In 2001, a second 21,000 sq. ft. facility was added, allowing us to expand areas to accommodate special projects and stability studies.

Our analysts are fully trained and re-certified annually, providing our clients with the assurance that their material, components, or product is tested in a timely and efficient manner with knowledgeable expertise.

Geneva Laboratories is FDA registered, GMP/GLP compliant, and certified to ISO 9001 and ISO 17025 standards.

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Products by Geneva Laboratories

By Geneva Laboratories

Plastics and other polymers intended for use in medical devices, implants or other systems associated with a medical process, must be shown to be suitable for use in the intended applications. USP <88> Biological Reactivity Tests, in Vivo offers guidance to the testing required to meet the... Read more »

By Geneva Laboratories

An important part of the manufacturing process for medical devices is determining the level and nature of viable microorganisms that are generated as a result of the process. By developing and following a routine, documented sampling plan, you are assured that your process remains under... Read more »

By Geneva Laboratories

Geneva Laboratories’ chemistry department provides quality compendial and non-compendial chemical analysis of raw materials and final product. Compendial testing of pharmaceuticals (APIs and drug products), food additives, and reagent chemicals is performed under one of the following... Read more »