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**
* Comprehensive microbiological and analytical testing to ensure product safety and regulatory compliance.
* Specialized services for Biocompatibility Testing (ISO 10993), including addressing requirements related to Carcinogenic, Mutagenic, or Toxic to Reproduction (CMR) and endocrine-disrupting substances above 0.1% w/w.
* Support for MDR transition strategies, including gap analysis and compliance readiness.
* A wide range of over 800 microbiological and analytical laboratory tests.
**Reputation / proof points**
* The Salt Lake City, Utah location is an FDA registered and ISO 17025 accredited facility.
* Offers a comprehensive collection of educational resources including blog posts, on-demand webinars, articles, podcasts, and whitepapers.
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**
* Comprehensive microbiological and analytical testing to ensure product safety and regulatory compliance.
* Specialized services for Biocompatibility Testing (ISO 10993), including addressing requirements related to Carcinogenic, Mutagenic, or Toxic to Reproduction (CMR) and endocrine-disrupting substances above 0.1% w/w.
* Support for MDR transition strategies, including gap analysis and compliance readiness.
* A wide range of over 800 microbiological and analytical laboratory tests.
**Reputation / proof points**
* The Salt Lake City, Utah location is an FDA registered and ISO 17025 accredited facility.
* Offers a comprehensive collection of educational resources including blog posts, on-demand webinars, articles, podcasts, and whitepapers.
Additional information
Nelson Labs provides extensive educational resources to aid clients in improving their testing processes and achieving better business outcomes. These resources include blog posts, webinars, articles, podcasts, and whitepapers, accessible through their website and the Sotera Health Academy. For clients navigating complex regulatory landscapes like the EU MDR, Nelson Labs offers expert advisory services to help understand requirements, conduct gap analyses, and ensure product compliance. Their approach to biocompatibility testing is tailored to the specific devices and their clinical use history, ensuring a targeted and effective evaluation process.
Key Highlights
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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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The Salt Lake City, Utah facility is FDA registered and ISO 17025 accredited.
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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Provides expert advisory services for MDR compliance and gap analysis.
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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Global headquarters in Salt Lake City, Utah, with a European Center of Excellence in Belgium.
Source
“The Salt Lake City, Utah location is the global headquarters of Nelson Labs.”
-
ISO 17025 accredited facility for laboratory testing.
Source
“It is a U.S. Food and Drug Administration (FDA) registered and ISO 17025 accredited facility.”
Buyer Snapshot
Best for
- Medical device manufacturers seeking ISO 10993 biocompatibility testing.
- Pharmaceutical companies requiring microbiological and analytical testing.
- Companies needing support with EU MDR compliance.
How engagement typically works
- Direct contact for testing inquiries and quotes.
- Access to expert advisors for regulatory and testing guidance.
- Utilizing a customer portal for sample submission and status updates.
Typical deliverables
- Biocompatibility test reports.
- Analytical and microbiological testing results.
- Regulatory compliance assessments.
- Expert advisory reports.
Good to know
- Best when requiring specialized laboratory testing and regulatory expertise for medical and pharmaceutical products.
Pricing
Model:
Per project
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
Minimum Project Size:
No minimum
Additional biocompatibility_testing Details
Iso10993 Standards Supported
ISO 10993
Test Types Offered
Biocompatibility testing, Microbiological testing, Analytical testing, Cytotoxicity, Sensitization, Irritation, Systemic toxicity, Genotoxicity, Implantation, Hemocompatibility
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
Custom
