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. They support clients from the initial concept through to commercialization.
**Expertise & scope**
* Comprehensive medical device testing services
* Preclinical research and development support
* Regulatory consulting for global compliance
* Ensuring device safety and efficacy
**Reputation / proof points**
* Leading global Contract Research Organization (CRO)
NAMSA is a global Contract Research Organization (CRO) specializing in medical device testing, preclinical research, and regulatory consulting. They support clients from the initial concept through to commercialization.
**Expertise & scope**
* Comprehensive medical device testing services
* Preclinical research and development support
* Regulatory consulting for global compliance
* Ensuring device safety and efficacy
**Reputation / proof points**
* Leading global Contract Research Organization (CRO)
Additional information
NAMSA's services are designed to ensure medical devices meet stringent safety and compliance standards required for global market access. Their expertise spans the entire product lifecycle, from early-stage development to post-market surveillance. Buyers can expect a partner focused on navigating complex regulatory landscapes and accelerating time-to-market for innovative medical technologies.
Key Highlights
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Global Contract Research Organization (CRO) specializing in medical device testing.
Source
“NAMSA is a leading global Contract Research Organization (CRO) specializing in medical device testing”
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Offers comprehensive services from concept to commercialization for medical devices.
Source
“They offer comprehensive services from concept to commercialization, ensuring device safety and compliance worldwide.”
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Focuses on ensuring device safety and compliance worldwide.
Source
“ensuring device safety and compliance worldwide.”
Certifications & Trust Signals
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Leading global Contract Research Organization (CRO).
Source
“NAMSA is a leading global Contract Research Organization (CRO)”
Buyer Snapshot
Best for
- Medical device manufacturers seeking comprehensive testing and regulatory support
- Companies needing to ensure global compliance for their devices
How engagement typically works
- Collaborative partnership from concept to commercialization
- Expert guidance on regulatory pathways
Typical deliverables
- Biocompatibility testing reports
- Preclinical study results
- Regulatory submission documentation
- Consulting advice
Good to know
- Best when requiring specialized expertise in medical device development and compliance
HQ:
North Canton, United States
Languages:
English
Timezones:
UTC, EST
Claim status:
Listed
Services & Capabilities
Biocompatibility Testing (ISO 10993 Program)
Countries:
United States, United Kingdom, Switzerland, Canada, Japan, Australia, Brazil, Europe, Asia
Industries:
Medical Devices
Pricing model:
Per project
Iso10993 Standards Supported:
ISO 10993-1, ISO 10993-5, USP <87>, USP <88>
Test Types Offered:
Cytotoxicity, Irritation, Systemic toxicity, Genotoxicity, Implantation, Hemocompatibility, Pyrogenicity
Is Accredited:
Yes
Glp Compliant:
Yes
Has In House Toxicology:
Yes
Toxicology Capabilities:
NAMSA offers a comprehensive suite of biocompatibility testing services, including cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, implantation, hemocompatibility, pyrogenicity, carcinogenicity, reproductive toxicity, biodegradation, and pharmacokinetics. They have in-house toxicology capabilities.
Regions Served:
North America, Europe, Asia
Lead Time Band:
Start in 0-2 weeks
Quote SLA:
3-5 business days
Minimum Project Size:
$50k+
Contact Types Supported:
Surface contact, External communicating, Implant
Duration Types Supported:
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Rush Available:
Yes
Sample Requirements:
NAMSA requires specific sample quantities and preparation methods depending on the test. Please contact NAMSA for detailed sample requirements.
Sample Return Policy:
Both options
Nda Support:
Yes
sterilization_microbiology_testing
Additional biocompatibility_testing Details
Iso10993 Standards Supported
ISO 10993-1, ISO 10993-18
Test Types Offered
Extractables and Leachables (E&L) testing, Chemical Characterization, Genotoxicity testing, Biocompatibility 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
3-5 business days
Sample Return Policy
Return, Dispose
Minimum Project Size
$50k+
Pricing Model
Per project
