About Nelson Laboratories
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 services that improve patient outcomes and minimize client risk. We know the products we test are as important as the patients they represent. It is why we set high standards, ensure accuracy, and work directly with clients to help solve complex issues. It is a comprehensive, detail-focused process we call “The Science of Success™.”
- Focusing on the client. We provide direct access to industry experts who understand our clients’ business and add value 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 which contributes to their success in providing healthy patient outcomes.
- Delivering value. We provide superior testing services and a personalized experience for every client and every project, offering industry-leading expertise, quality, and results that deliver exceptional value to our clients.
Our scientists participate on industry-leading committees and help define the standards for the evaluation of safety and efficacy of medical devices, tissue, and pharmaceuticals including ISO, AAMI, ASTM, AATB, PDA and others. We also participate in the National Registry of Certified Microbiologists (NRCM) and currently have the largest number of registered microbiologists in the US, outside of government.
Through our network of 10 lab facilities in eight countries, we provide test services to over 4,000 medical device, pharmaceutical, and life science companies in 60 countries. We are part of the Sterigenics International family of companies that includes 48 facilities in 10 countries focused on improving public health. Combined we have the largest fully integrated laboratory and sterilization company in the world.
- Microbiological Analysis
- Barrier Material Tests
- Product Validation & Lot Release
- EO Sterilization Validations
- General Analytical Tests
- Toxicology & Biocompatibility
- Disinfectant Tests
- Facility & Process Validation
- Package Testing
- Filter Challenge/Sterilization
- Microbial Identification
- General Routine Testing
- General Physical Tests
- Steam Sterilization Validations
- Reusable Device Studies
- Radiation Sterilization Validations
Medical Device Testing Categories
Getting ready to launch a medical device? Nelson Laboratories will help you ensure your product meets requirements and validate your product claims. Working with Nelson Laboratories gives you access to in-depth testing expertise, innovative testing techniques, and world-class facilities and equipment – all designed to help 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
- Disinfectant tests
- Barrier Materials tests
Pharmaceutical Testing Categories
Working on the next pharmaceutical breakthrough? Trust Nelson Laboratories to help you navigate the maze of complicated testing requirements and deliver the actionable test data you need to get your product to market. With Nelson Laboratories you will get more than a testing partner that specializes in an impressive number of pharmaceutical tests; you will 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, 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
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.
- 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: Bicompatibility and material characterization risk assessments (ISO 10993), Sterilization validations (EO/Steam/Radiation), Packaging validation (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.
To see how we can help you, please visit www.nelsonlabs.com or call +1 801 290 7502.