Nelson Labs
Nelson Laboratories, LLC
★★★★★
3.2
/ 5
•
11 reviews
Nelson Labs is a leading global provider of laboratory testing and expert advisory services for MedTech and pharmaceutical companies. They offer comprehensive microbiological and analytical testing to ensure product safety and regulatory compliance.
Nelson Labs is a premier global provider of laboratory testing and expert advisory services tailored for MedTech and pharmaceutical companies. With a strong commitment to safeguarding global health, they offer comprehensive microbiological and analytical testing, ensuring critical compliance and product safety. Their expertise spans the entire product development lifecycle, guiding clients through complex regulatory landscapes like the EU MDR. Nelson Labs provides end-to-end solutions, from initial planning and testing to regulatory and quality advisory services, helping manufacturers bring safe and compliant devices to market. With a worldwide network of labs and facilities, Nelson Labs emphasizes personalized service, timely turnaround, and exceptional quality. Their track record of reliability and a high percentage of repeat customers underscore their dedication to building strong, long-standing partnerships focused on improving and saving lives through rigorous scientific evaluation.
About
**Who they are**
Nelson Labs is a global provider of laboratory testing and expert advisory services for medical technology and pharmaceutical companies. They are headquartered in Salt Lake City, Utah, with a European Center of Excellence located in Belgium.
**Expertise & scope**
* Offers comprehensive microbiological and analytical testing to ensure product safety and regulatory compliance.
* Specializes in Biocompatibility Testing, including guidance on ISO 10993 standards.
* Provides services to help manufacturers comply with new MDR regulations, including gap analysis and evaluation of regulatory standards.
* Expertise includes chemical characterization testing of medical devices (ISO 10993-18).
* Offers advisory services such as Testing Advisory and Regulatory & Quality Advisory.
**Reputation / proof points**
* The Salt Lake City, Utah location is an FDA registered and ISO 17025 accredited facility.
* The Salt Lake City campus offers over 800 microbiological and analytical laboratory tests.
* Has a European Center of Excellence in Belgium.
Nelson Labs is a global provider of laboratory testing and expert advisory services for medical technology and pharmaceutical companies. They are headquartered in Salt Lake City, Utah, with a European Center of Excellence located in Belgium.
**Expertise & scope**
* Offers comprehensive microbiological and analytical testing to ensure product safety and regulatory compliance.
* Specializes in Biocompatibility Testing, including guidance on ISO 10993 standards.
* Provides services to help manufacturers comply with new MDR regulations, including gap analysis and evaluation of regulatory standards.
* Expertise includes chemical characterization testing of medical devices (ISO 10993-18).
* Offers advisory services such as Testing Advisory and Regulatory & Quality Advisory.
**Reputation / proof points**
* The Salt Lake City, Utah location is an FDA registered and ISO 17025 accredited facility.
* The Salt Lake City campus offers over 800 microbiological and analytical laboratory tests.
* Has a European Center of Excellence in Belgium.
Additional information
Nelson Labs provides a wealth of educational resources to assist buyers in navigating complex testing and regulatory landscapes. These resources include blog posts, on-demand webinars, articles, podcasts, and whitepapers, all designed to enhance testing processes and improve business outcomes. Buyers can access a full library of these offerings, including specialized content on topics like ISO 10993-1 and MDR compliance, to better understand their testing needs and the services available to meet them.
Key Highlights
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The Salt Lake City, Utah location is an FDA registered and ISO 17025 accredited facility.
Source
“The Salt Lake City, Utah location is the global headquarters of Nelson Labs. It is a U.S. Food and Drug Administration (FDA) registered and ISO 17025 accredited facility.”
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Offers over 800 microbiological and analytical laboratory tests from its Salt Lake City campus.
Source
“The five-building campus offers over 800 microbiological and analytical laboratory tests.”
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Provides expert advisory services for regulatory and quality compliance, including MDR transition strategies.
Source
“Nelson Labs has a team of expert advisors and a process available to help manufacturers bring their devices into compliance with the new MDR.”
Certifications & Trust Signals
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ISO 17025 accredited facility in Salt Lake City, Utah.
Source
“It is a U.S. Food and Drug Administration (FDA) registered and ISO 17025 accredited facility.”
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FDA registered facility in Salt Lake City, Utah.
Source
“It is a U.S. Food and Drug Administration (FDA) registered and ISO 17025 accredited facility.”
Buyer Snapshot
Best for
- Medical device manufacturers
- Pharmaceutical companies
How engagement typically works
- Direct engagement for testing services
- Consultation for regulatory and quality advisory
Typical deliverables
- Biocompatibility testing reports
- Chemical characterization reports
- Regulatory compliance assessments
- Expert advisory services
Good to know
- Best when requiring specialized laboratory testing and expert guidance for product safety and regulatory compliance.
HQ:
Salt Lake City, US
Languages:
English
Timezones:
MST
Claim status:
Listed
Services & Capabilities
Biocompatibility Testing (ISO 10993 Program)
Countries:
United States, China, Mexico, Europe, Asia
Industries:
Medical Devices
Pricing model:
Per project
Iso10993 Standards Supported:
ISO 10993-1, ISO 10993-18
Test Types Offered:
Cytotoxicity, Sensitization, Irritation, Systemic toxicity, Genotoxicity, Implantation, Hemocompatibility, Pyrogenicity, Carcinogenicity, Reproductive toxicity, Biodegradation, Pharmacokinetics, Other
Is Accredited:
Yes
Accreditation Body:
ISO 17025
Contact Types Supported:
Surface contact, External communicating, Implant
Duration Types Supported:
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Sample Requirements:
Please include your name, company, location, and details about your desired testing.
Regions Served:
Global, Europe
Lead Time Band:
Start in 0-2 weeks
Quote SLA:
< 24 hours
Additional biocompatibility_testing Details
Iso10993 Standards Supported
ISO 10993-1, ISO 10993-18
Test Types Offered
Biocompatibility testing, Microbiological testing, Analytical testing, Chemical characterization testing
Contact Types Supported
Surface contact, External communicating, Implant
Duration Types Supported
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Lead Time Band
Start in 0-2 weeks
Quote SLA
< 24 hours
Pricing Model
Per project
