Medical Device Qualified Supplier Directory
Qualifications: FDA Registered, CGMP Certified, Supplier to Medical Manufacturers, Exhibitor in at least 2 MD&M and/or MEDTEC shows
Markets Supplied: North America, Europe
Nelson Labs, a Sotera Health company, is the industry-leading global provider of lab testing and expert consulting services. We perform microbiological and analytical laboratory tests across the medical device, pharmaceutical, and tissue industries. The company is regarded as a best-in-class partner with a strong track record of collaborating with customers to solve complex issues.
With the addition of Nelson Labs Europe, we are the leading global extractables and leachables lab testing platform. We have over 700 scientists, technicians, and service specialists who diligently performing more than 700 rigorous tests in 13 global laboratory locations. With decades of expertise, we stand behind the quality of our results and the strength of our customer partnerships.
Why Choose Nelson Laboratories
Every year, hundreds of medical device, pharmaceutical, and tissue companies make Nelson Labs their testing laboratory of choice. For them, the decision is easy. Nelson Labs is a clear leader in the microbiology testing industry, offering more than 700 laboratory tests and employing more than 700 scientists and staff in state-of-the-art facilities. We are known for exceptional quality and rigorous testing standards, but it’s our focus on the bigger picture that sets us apart. We look beyond test results and partner with you to achieve your long-term business goals — mitigating risk, being first to market, and succeeding with your customers.
Companies choose Nelson Laboratories for our:
- Thought leaders and approachable experts. We give you direct access to industry authorities who understand your business and add value every step of the way.
- Customer-centric culture. We take the time to understand your vision. Your goals become our goals.
- Real-time project management tools and a dedicated client portal. We provide proactive information, keeping you informed and in control.
- Metric-driven testing processes. We're our own toughest customer, holding ourselves to goals exceeding 99% for things that matter most to you, like quality, turn-around time, and testing accuracy.
- Global compliance expertise and support. We act as a trusted advisor, helping you navigate the ever-changing compliance landscape.
See how we can help you mitigate risk, be first to market, and succeed with your customers.
- 1985 by Dr. Jerry R. Nelson and Lynda S. Nelson
800+ with more than 700 scientists
75+ registered and specialist microbiologists (NRCM)
- 13 global lab sites in the US, Mexico, Europe and China
- Salt Lake City, UT
- More than 700 microbiological and analytical tests
- ASTM, ISO, AAMI, ANSI, IEST, PDA, AATB, and more
- Nelson Labs facilities are FDA-registered as a GMP, GLP, and GTP testing lab with ISO 17025 accreditation
- Biocompatibility & Toxicology
- Chemistry Testing
- Clinical Reprocessing Validations
- Extractables & Leachables
- Facility & Process Validation
- Packaging Solutions
- Protective Barriers & Material Performance
- Sterility Assurance
- Sterilization Validations
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 .
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.
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.
Nelson Labs Expert Advisory Services offers an unparalleled breadth of MedTech and pharmaceutical experience to help our clients deliver safe and effective products to market. Our Expert Advisory Service encompasses product development, facility and process validation, and product performance testing, as well as regulatory support.
Each expert advisor brings a unique perspective based on years of industry, regulatory, and scientific expertise. By participating in industry groups, actively working on the standards committees (AAMI/ISO/ASTM/PDA), and partnering with a broad range of MedTech and pharma companies on many product types, our experts bring a breadth of experience to each relationship. Although our lab processes over 50,000 projects each year, our expert advisors ensure success for our clients one project at a time.
By focusing on what matters most, we help our clients deliver life-saving products with every test through our value-added advisory approach.
- 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.
- 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.
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.
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 the form below to select your expert and submit your question.
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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For more information contact Nelson Laboratories, LLC
Aa. Louis-Hansens Alle 11
T +45 (0) 49 12 79 72
Gibraltar Laboratories, Fairfield, New Jersey, USA
122 Fairfield Road
T (973) 227-6882
Itasca, Illinois, USA
1500 W. Thorndale Ave
T (630) 285-9121
Mexico City, Mexico
James Watt No. 22
T + 52 (55) 2620 9076
Nelson Labs Europe – Leuven, Belgium
T +32 (0) 16 40 04 84
Ontario, California, USA
687 S. Wanamaker Avenue
T (909) 969-2302