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, and operate a European Center of Excellence in Belgium.

**Expertise & scope**
* Comprehensive microbiological and analytical testing to ensure product safety and regulatory compliance.
* Specialized services for Biocompatibility Testing, including ISO 10993 standards.
* Expert advisory services for navigating regulatory requirements, such as the EU MDR.
* Testing for carcinogenicity, mutagenicity, reproductive toxicity (CMR), and endocrine-disrupting substances.
* Chemical characterization testing for medical devices.

**Reputation / proof points**
* The Salt Lake City, Utah location is an FDA-registered and ISO 17025 accredited facility.
* Offers over 800 microbiological and analytical laboratory tests.
* Provides educational resources including blog posts, webinars, articles, videos, and whitepapers.

Additional information

Nelson Labs assists manufacturers in understanding and complying with regulatory standards, including the EU MDR. They offer gap analysis services to assess current readiness and help devices achieve compliance. Their approach to biocompatibility evaluation is tailored to the number and range of devices, as well as their clinical use history. They also address specific MDR requirements, such as justifications for the presence of CMR and endocrine-disrupting substances above 0.1% weight by weight.

Key Highlights

  • Offers over 800 microbiological and analytical laboratory tests. Source
    “The five-building campus offers over 800 microbiological and analytical laboratory tests.”
  • 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.”
  • Provides expert advisory services for navigating regulatory requirements like the EU MDR. 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.”
  • Offers educational resources including on-demand webinars, articles, and whitepapers. Source
    “Here you’ll find a complete collection of blog posts, brochures, on-demand webinars, published articles, videos and whitepapers”

Certifications & Trust Signals

  • ISO 17025 accredited facility. Source
    “It is a U.S. Food and Drug Administration (FDA) registered and ISO 17025 accredited facility.”
  • FDA registered facility. 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
  • Testing services
  • Advisory services
Typical deliverables
  • Biocompatibility test reports
  • Regulatory compliance assessments
  • Analytical testing results
Good to know
  • Best when requiring specialized laboratory testing and expert regulatory guidance for medical devices.
HQ: Salt Lake City, US
Languages: English
Timezones: MST
Status: listed

Services & Capabilities

Biocompatibility Testing (ISO 10993 Program)

Countries: United States, China, Mexico, Europe, Asia
Industries: Medical Devices
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

Additional biocompatibility_testing Details

Iso10993 Standards Supported
ISO 10993-1, ISO 10993-18
Test Types Offered
Biocompatibility testing, Chemical characterization, Microbiological testing, Analytical 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
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