NAMSA
★★★★★
3.5
/ 5
•
16 reviews
NAMSA is a leading global Contract Research Organization (CRO) specializing in medical device testing, preclinical research, and regulatory consulting. They offer comprehensive services from concept to commercialization, ensuring device safety and compliance worldwide.
NAMSA is a premier global Contract Research Organization (CRO) with over 50 years of experience dedicated to advancing medical device innovation and safety. They offer a comprehensive suite of services including consulting & strategy, preclinical research, clinical research, and extensive medical device testing. With a strong focus on regulatory compliance, NAMSA provides expert guidance for US FDA and EU MDR/IVDR submissions, biological safety evaluations, and market research. Their state-of-the-art, GLP-compliant facilities in the United States and Europe conduct over 118,000 tests annually, including biocompatibility, extractables and leachables (E&L), and genotoxicity testing. NAMSA's team of over 1,400 professionals, including toxicologists, scientists, and regulatory experts, ensures that medical devices are safe, effective, and compliant with global standards. They are trusted by thousands of medical device and IVD companies worldwide to shorten time-to-market and ensure product success.
About
**Who they are**
NAMSA is a global Contract Research Organization (CRO) specializing in medical device testing, preclinical research, and regulatory consulting, serving the medical device and IVD industries since 1967.
**Expertise & scope**
* Leading global provider of biocompatibility testing, including ISO 10993 standards and chemical characterization for extractables and leachables (E&L).
* Offers comprehensive services from concept to commercialization, ensuring device safety and compliance worldwide.
* Specializes in medical device testing, preclinical research, and regulatory consulting, including US FDA and EU MDR/IVDR compliance.
* Provides biological safety consulting, toxicological risk assessment, and market research for medical devices and IVDs.
* Conducts thousands of genotoxicity tests annually to assess potential carcinogenic effects.
**Reputation / proof points**
* Over 1,400 specialists available to assist clients.
* Serves over 3,000 medical device and In Vitro Diagnostic companies annually.
* Operates GLP-compliant and AAALAC-accredited facilities in the United States and Europe.
* Has conducted over 118,000 medical device tests in the past year.
NAMSA is a global Contract Research Organization (CRO) specializing in medical device testing, preclinical research, and regulatory consulting, serving the medical device and IVD industries since 1967.
**Expertise & scope**
* Leading global provider of biocompatibility testing, including ISO 10993 standards and chemical characterization for extractables and leachables (E&L).
* Offers comprehensive services from concept to commercialization, ensuring device safety and compliance worldwide.
* Specializes in medical device testing, preclinical research, and regulatory consulting, including US FDA and EU MDR/IVDR compliance.
* Provides biological safety consulting, toxicological risk assessment, and market research for medical devices and IVDs.
* Conducts thousands of genotoxicity tests annually to assess potential carcinogenic effects.
**Reputation / proof points**
* Over 1,400 specialists available to assist clients.
* Serves over 3,000 medical device and In Vitro Diagnostic companies annually.
* Operates GLP-compliant and AAALAC-accredited facilities in the United States and Europe.
* Has conducted over 118,000 medical device tests in the past year.
Additional information
NAMSA emphasizes a holistic approach to medical device development, integrating preclinical research, clinical trials, biological safety testing, and regulatory submissions. They highlight their extensive experience, having conducted over 118,000 medical device tests in the last year, and work with clients through the entire product journey, from study design to regulatory support. Their services are designed to ensure device safety and compliance with global standards, including FDA, EU MDR, and IVDR requirements. Engagement typically involves close collaboration with their team of experts, including former Notified Body reviewers and toxicologists, to navigate complex regulatory landscapes and achieve market access efficiently.
Key Highlights
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World leader in Extractables and Leachables (E&L) testing, having been the first CRO to perform chemical characterization on medical device materials and helped develop current standards.
Source
“NAMSA was the first CRO to start performing chemical characterization on medical device materials and helped develop the standards in use today.”
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Conducts thousands of genotoxicity tests annually to ensure patient safety from potential DNA or gene changes.
Source
“NAMSA conducts thousands of genotoxicity tests each year to determine if chemicals released from a device might cause gene mutations...”
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Offers comprehensive regulatory consulting for US FDA and EU MDR/IVDR compliance, including former Notified Body staff expertise.
Source
“Our consultants combine NAMSA’s institutional knowledge with their own real world expertise to ensure your continued compliance with regulations.”
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Operates state-of-the-art testing facilities with Centers of Excellence in the US and Germany for chemical characterization.
Source
“NAMSA provides state of the art testing for chemical characterization of medical devices with two Centers of Excellence in the US and Germany.”
Certifications & Trust Signals
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Serving the medical device and IVD industries since 1967.
Source
“NAMSA has been serving the medical device and IVD industries since 1967 and has a highly experienced team ready to serve you.”
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Operates GLP-compliant and AAALAC-accredited preclinical laboratory facilities in the United States and Europe.
Source
“Unparalleled preclinical laboratory support for sponsors at GLP-compliant and AAALAC-accredited facilities in the United States and Europe.”
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More than 1,400 specialists on staff to support client projects.
Source
“Our team of 1,400 specialists are ready to help you conduct market research, preclinical studies, clinical trials, biological safety testing, regulatory submissions, and much more.”
Buyer Snapshot
Best for
- Medical device and IVD manufacturers seeking comprehensive testing and regulatory support.
- Companies requiring specialized biocompatibility and extractables/leachables testing.
- Clients needing assistance with US FDA and EU MDR/IVDR submissions and compliance.
How engagement typically works
- Collaborative study design, testing, and regulatory support.
- Integrated services across preclinical, clinical, and consulting domains.
- Strategic planning and execution for market entry and compliance.
Typical deliverables
- Biological Evaluation Plans and Reports.
- Chemical Characterization Reports for E&L testing.
- Toxicological Risk Assessments.
- Regulatory submission support (e.g., 510(k), PMA, CE Marking documentation).
Good to know
- Best when requiring specialized expertise in medical device safety and compliance.
- Best when needing a partner with extensive experience and global reach.
HQ:
United States
Languages:
English
Status:
listed
Services & Capabilities
Biocompatibility Testing (ISO 10993 Program)
Countries:
United States, United Kingdom, Switzerland, Canada, Japan, Australia, Brazil, Europe, Asia
Industries:
Medical Devices
Iso10993 Standards Supported:
ISO 10993-1, ISO 10993-18, ISO 10993-5
Test Types Offered:
Cytotoxicity, Genotoxicity, Hemocompatibility
Is Accredited:
Yes
Glp Compliant:
Yes
Has In House Toxicology:
Yes
Toxicology Capabilities:
NAMSA conducts thousands of genotoxicity tests each year to determine if chemicals released from a device might cause gene mutations, changes in chromosome structure, or other DNA or gene changes which may lead to a carcinogenic effect. Hemocompatibility tests are conducted to evaluate the adverse effects of blood-contacting medical devices or biomaterials on blood or blood components. Cytotoxicity tests are used to determine the lysis (death) of cells, colony formation, inhibition of cell growth, and other effects on cells caused by medical devices, bio-materials, or their extracts utilizing cell culture techniques.
Regions Served:
North America, Europe, Asia
sterilization_microbiology_testing
Additional biocompatibility_testing Details
Iso10993 Standards Supported
ISO 10993-1, ISO 10993-18
Test Types Offered
Biocompatibility Testing, Chemical Characterization, Extractables and Leachables (E&L) Testing, Genotoxicity Testing, Toxicological Risk Assessment
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
3-5 business days
Sample Return Policy
Return, Dispose
Minimum Project Size
$50k+
Pricing Model
Per project, Custom
