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 offer comprehensive microbiological and analytical testing to ensure product safety and regulatory compliance.
**Expertise & scope**
* Expert advisory services for MedTech and pharmaceutical companies.
* Comprehensive microbiological and analytical testing.
* Services to ensure product safety and regulatory compliance.
* Assistance with understanding MDR requirements and conducting gap analyses.
* Evaluation of regulatory standards and justification for CMR and endocrine-disrupting substances above 0.1% w/w.
* Biocompatibility testing, including guidance on ISO 10993-1.
* Chemical characterization testing (ISO 10993-18).
**Reputation / proof points**
* Global headquarters in Salt Lake City, Utah, which is an FDA registered and ISO 17025 accredited facility.
* European Center of Excellence located in Belgium.
* Offers over 800 microbiological and analytical laboratory tests.
Nelson Labs is a global provider of laboratory testing and expert advisory services for medical technology and pharmaceutical companies. They offer comprehensive microbiological and analytical testing to ensure product safety and regulatory compliance.
**Expertise & scope**
* Expert advisory services for MedTech and pharmaceutical companies.
* Comprehensive microbiological and analytical testing.
* Services to ensure product safety and regulatory compliance.
* Assistance with understanding MDR requirements and conducting gap analyses.
* Evaluation of regulatory standards and justification for CMR and endocrine-disrupting substances above 0.1% w/w.
* Biocompatibility testing, including guidance on ISO 10993-1.
* Chemical characterization testing (ISO 10993-18).
**Reputation / proof points**
* Global headquarters in Salt Lake City, Utah, which is an FDA registered and ISO 17025 accredited facility.
* European Center of Excellence located in Belgium.
* Offers over 800 microbiological and analytical laboratory tests.
Additional information
Nelson Labs provides a wealth of educational resources to aid in testing processes and business results. These include blog posts, on-demand webinars, articles, podcasts, and whitepapers. Buyers can access a full library of these offerings, including resources from the Sotera Health Academy. The company emphasizes a structured approach to biocompatibility evaluation, often involving a 3-step process: Plan, Test, Evaluate, particularly in relation to standards like ISO 10993-1. They also highlight their role in navigating complex regulatory landscapes such as the EU MDR, offering services to help manufacturers achieve compliance.
Key Highlights
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Global headquarters in Salt Lake City, Utah, 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.
Source
“The five-building campus offers over 800 microbiological and analytical laboratory tests.”
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European Center of Excellence located in Belgium.
Source
“Our European Center of Excellence, located in Belgium, is ready to help you with all your testing and business needs.”
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Provides comprehensive resources including blog posts, webinars, articles, podcasts, and whitepapers.
Source
“Here you’ll find a complete collection of blog posts, on-demand webinars, articles, podcasts and whitepapers”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Medical device manufacturers seeking biocompatibility testing.
- Pharmaceutical companies requiring microbiological and analytical testing.
- Companies navigating EU MDR compliance.
How engagement typically works
- Direct consultation with expert advisors.
- Access to extensive educational resources.
- Laboratory testing services.
Typical deliverables
- Biocompatibility test reports.
- Chemical characterization reports.
- Regulatory compliance assessments.
- Expert advisory opinions.
Good to know
- Best when requiring specialized laboratory testing and regulatory guidance for medical devices.
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, Genotoxicity, Carcinogenicity, Reproductive toxicity, 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
Minimum Project Size:
No minimum
Toxicology Capabilities:
Experts sit on standards committees and have created many of the tests relied upon. Provide expert advisory services for MedTech and pharmaceutical companies. Guide along product development lifecycle to ensure product safety. Assist customers with impurity investigations. Expertise in chemical characterization of medical devices (ISO 10993-18).
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
Sample Return Policy
Return, Dispose
Minimum Project Size
No minimum
Pricing Model
Per project
