Medical DeviceQualified Supplier Directory

Nelson Laboratories Inc.

6280 S. Redwood Rd.
Salt Lake City, 
UT  84123  us
Tel: 801/290-7500
Fax: 801/290-7998


The Science of Success™
Nelson Laboratories is a leading provider of microbiology testing and consulting services for MedTech companies. With a strong belief that every test matters, we go beyond exceptional quality and rigorous testing standards to provide solutions that improve patient outcomes and minimize client risk. We know the products we test are as important as the patients they represent. It's why we set such high standards, ensure accuracy, and work directly with clients to help solve complex issues. It’s a comprehensive, detail-focused process we call “The Science of Success™.”

  • Focusing on the customer. We provide direct access to industry experts who understand our clients’ business and add value at every step by collaborating to find solutions to complex problems.
  • Impacting lives. We understand the test results we generate ensure the safety and efficacy of our clients’ products and their success in providing healthy patient outcomes. 
  • Delivering value. We provide superior testing solutions and personalized service for every client and every project, offering industry-leading expertise, quality, and results that deliver exceptional value to our clients.

To see how we can help you solve complex problems, improve patient outcomes, and deliver greater value, visit www.nelsonlabs.com.  

Quick Facts

Founded:                 1985 by Dr. Jerry R. Nelson and Lynda S. Nelson

Employees:             500+ with more than 200 scientists
                                   60+ registered & specialist microbiologists (NRCM)

Capacity:                 125,000 sq ft (three buildings)
                                   85+ labs
                                   Custom-built 3,000 sq. ft. cleanroom

Headquarters:        Salt Lake City, UT

Capabilities:            More than 400 microbiological and analytical tests

Committee             
Memberships:        ASTM, ISO, AAMI, ANSI, IEST, PDA, AATB, and more

Certifications:         Nelson Laboratories is FDA registered and third-party accredited to ISO 17025 standards       (ACLASS). 
Nelson Laboratories is a GLP facility.

Test Services

Medical Device Testing Categories
Getting ready to launch a medical device? Nelson Labs will help you ensure your product meets Federal requirements and validate your product claims. Working with Nelson Labs gives you access to in-depth testing expertise, innovative testing techniques, and world-class facilities and equipment – all designed to help you get your products to market faster and minimize risk. Learn about the wide range of tests we offer for facility validation, raw materials screening, sterilization and packaging validations, biocompatibility, cleanroom and isolator facilities, routine quality control tests, and reusable device studies.

  • Ethylene Oxide Sterilization
  • Radiation Sterilization
  • Product Validation & Lot Release tests
  • Toxicology & Biocompatibility
  • Steam Sterilization Validations
  • Reusable Device Studies
  • Package Testing
  • Microbiological Analysis
  • Microbial Identification
  • General Routine Testing
  • General Physical Testing
  • General Analytical tests
  • Facility & Process Validations
  • Environmental & Water System Validations
  • Disinfectant tests
  • Barrier Materials tests

Pharmaceutical Testing Categories
Working on the next pharmaceutical breakthrough? Trust Nelson Labs to help you navigate the maze of complicated testing requirements and deliver the actionable test data you need to get your product on the market. With Nelson Labs you’ll get more than a testing partner that specializes in an impressive number of pharmaceutical tests, you’ll get a partner that understands the unique requirements of your business and industry. Make our team your team for filter validations, facility validation, disinfectant studies, container integrity studies, preservative effectiveness studies, cleanroom and isolator facilities, antibiotic potency assays, sterilization and packaging validations, and routine quality control tests.

  • Filter Challenge/Sterilization tests
  • Disinfectant tests
  • Facility & Process Validation
  • General Analytical tests
  • General Routine tests
  • Microbial Identification
  • Microbiological Analysis
  • Package Testing
  • Product Validation & Lot Release

Processed Tissue Categories
Need to comply with tissue regulations? With the implementation of current good tissue practices (CGTP), tissue banks need to consider many types of validation and routine testing. Nelson Labs can help you comply with the new regulations with a variety of processed tissue validations and tests. Put our years of experience working with tissue banks and related industries to work for you and let us create validations and implement process controls that fit your exact needs.

  • Tissue tests
  • Product Validation & Lot Release
  • Microbial Identification
  • General Routine tests
  • General Analytical tests

ConsultingServices

Nelson Laboratories Technical Consulting offers an unparalleled breadth of MedTech experience to help our clients deliver safe and effective products to market. Our Technical Consulting Services encompasses product development, facility and process validation, product performance testing as well as regulatory support.

Discovery Team

  • Observation and onsite review of client processes, quality management systems, validation files and product development phase gates.
  • Assessment and needs discovery related to product development to support validation for regulatory compliance and product submissions.
  • Collaborative development of process changes and tailored solutions for continuous product improvement.

Education

  • Onsite and client-specific training related to industry best practices, current regulatory and test guidance.
  • Custom webinars for client training, regulatory updates and product-specific case studies.

Technical Consulting

  • Product design file review and design phase input
  • Facility validations (water systems, environmental and process controls)
  • Test plans, protocols and written justifications for method selection related to:
    • Biocompatibility and material characterization risk assessments (ISO 10993)
    • Sterilization validations (EO/Steam/Radiation)
    • Packaging validations (ISO 11607)
    • Reusable and reprocessed devices (AAMI TIR 12/30)
    • Product-specific validations and failure investigations
    • Development and review of product IFUs/DFUs
    • Product or family groupings
    • Unique process validations
  • Regulatory support for submissions, product changes, detentions or rejection notices.

Ask an Expert

If you have a challenging testing question, we have an answer. Our approachable experts are always happy to respond to your questions. They know how to effectively communicate with anyone – regardless of testing background. Get to know our industry-recognized scientists and their areas of expertise. Use this form to select your expert and submit your question.

Education

We believe in the power of education. That’s why we’ve created numerous opportunities for you to fine-tune your skills or learn something new. If you can’t get away from the office, register for a webinar and get helpful, relevant information from the convenience of your desk. If you are on the road, join us at one of our seminars for in-person training or find out at which industry events we’ll be presenting.

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