Medical Device Directory

Geneva Laboratories

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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.
Competitors of Geneva Laboratories
  • Advanced Cleanroom Microclean (ACM)

    ACM (Advanced Cleanroom Microclean), founded in 1982, was born on the West Coast and shortly after expanded nationwide. ACM was the first company in the USA established to fill the need for specialized cleanroom cleaning services. Originally servicing the Aerospace Industry in the early 80’s,...
  • QleanAir Scandinavia

    QleanAir Scandinavia cleanroom and hazardous drug storage work flow design technologies promote USP 797/800 compliance and meet all requirements of ISO Certifications, and all State Boards of Pharmacy and Joint Commission requirements. Our cleanrooms have integrated intelligent monitoring...
  • Sterigenics International, Inc.

    Over 50 years experience, and a team of industry experts, Sterigenics is the world leader in contract sterilization. With over 40 facilities spanning accross North America, Europe and Asia, Sterigenics services the medical, pharmaceutical, cosmetic, material modification and consumer safety...
Products by Geneva Laboratories
  • Toxicology / Biocompatibility Testing

    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
  • Microbiology Testing

    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
  • Chemistry Testing

    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