NAMSA
★★★★★
3.5
/ 5
•
16 reviews
NAMSA is a leading CRO specializing in medical device testing, preclinical research, and regulatory consulting. They offer comprehensive services to ensure device safety, efficacy, and compliance worldwide.
NAMSA is a premier Contract Research Organization (CRO) with extensive experience in the medical device and In Vitro Diagnostic (IVD) industries. Founded in 1967, NAMSA provides a comprehensive suite of services designed to support clients from concept to commercialization. Their expertise spans preclinical research, clinical trials, and a wide array of testing services, including microbiology, biocompatibility, and sterility testing. With a global team of over 1,400 specialists, NAMSA offers unparalleled support for regulatory submissions and compliance. They are adept at navigating complex regulatory landscapes, including FDA submissions (510(k), PMA, De Novo) and European regulations (MDR, IVDR). Their consulting services cover strategic planning, biological safety assessments, toxicological risk assessments, and post-market surveillance, ensuring devices meet the highest standards of safety and efficacy. NAMSA operates state-of-the-art, GLP-compliant and AAALAC-accredited facilities in the United States and Europe. They conduct over 100,000 tests annually, solidifying their position as a leader in medical device research and development support. Companies trust NAMSA to ensure their products are safe, effective, and compliant with global regulatory requirements.
About
**Who they are**
NAMSA is a Contract Research Organization (CRO) specializing in medical device testing, preclinical research, and regulatory consulting. They focus on ensuring device safety, efficacy, and compliance for clients globally.
**Expertise & scope**
* Comprehensive medical device testing
* Preclinical research services
* Regulatory consulting for global compliance
* Services aimed at ensuring device safety and efficacy
**Reputation / proof points**
* Leading CRO in their specialization
NAMSA is a Contract Research Organization (CRO) specializing in medical device testing, preclinical research, and regulatory consulting. They focus on ensuring device safety, efficacy, and compliance for clients globally.
**Expertise & scope**
* Comprehensive medical device testing
* Preclinical research services
* Regulatory consulting for global compliance
* Services aimed at ensuring device safety and efficacy
**Reputation / proof points**
* Leading CRO in their specialization
Additional information
NAMSA's services are crucial for medical device manufacturers navigating complex regulatory landscapes. Their expertise in testing and preclinical research helps clients validate device performance and safety before market entry. Engagement typically involves detailed project planning to align with specific device development timelines and regulatory submission requirements. Buyers should be prepared to provide comprehensive device documentation and specifications to facilitate accurate testing and consulting.
Key Highlights
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Leading CRO specializing in medical device testing and preclinical research.
Source
“NAMSA is a leading CRO specializing in medical device testing, preclinical research, and regulatory consulting.”
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Offers comprehensive services for device safety, efficacy, and global compliance.
Source
“They offer comprehensive services to ensure device safety, efficacy, and compliance worldwide.”
Certifications & Trust Signals
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Recognized as a leading CRO in the medical device sector.
Source
“NAMSA is a leading CRO specializing in medical device testing, preclinical research, and regulatory consulting.”
Buyer Snapshot
Best for
- Medical device companies seeking testing and regulatory support
- Organizations requiring preclinical research for device development
How engagement typically works
- Project-based consulting and testing
- Collaborative research partnerships
Typical deliverables
- Test reports and data
- Preclinical study results
- Regulatory submission guidance
Good to know
- Best when clients have clear device specifications and development goals.
HQ:
North Canton, United States
Languages:
English
Timezones:
UTC, EST
Claim status:
Listed
Services & Capabilities
Sterilization + Microbiology Validation
Countries:
United States, United Kingdom, Switzerland, Canada, Japan, Australia, Brazil, Europe, Asia
Industries:
Medical Devices
Pricing model:
Custom pricing
Sterilization Methods Supported:
EtO (Ethylene Oxide), Steam (Moist Heat)
Validation Types Offered:
Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Full validation (IQ/OQ/PQ), Revalidation
Microbiology Tests Offered:
Bioburden, Sterility, Bacterial Endotoxin (LAL), Environmental monitoring
Is Accredited:
Yes
GMP Compliant:
Yes
Glp Compliant:
Yes
Has In House Sterilization:
Yes
Has In House Microbiology:
Yes
Lead Time Band:
Start in 4-8 weeks
Sample Return Policy:
Both options
Regions Served:
United States, Europe, Asia, Japan
Standards Supported:
ISO 11135 (EtO), ISO 17665 (Steam), ISO 11737-1 (Bioburden), ISO 11737-2 (Sterility)
Quote SLA:
3-5 business days
Minimum Project Size:
$25-50k
Additional sterilization_microbiology_testing Details
Sterilization Methods Supported
EtO, Steam (Moist Heat), Gamma Radiation, E-Beam, X-Ray, Plasma, Vaporized Hydrogen Peroxide
Validation Types Offered
Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Full validation (IQ/OQ/PQ), Revalidation
Microbiology Tests Offered
Bioburden, Sterility, Bacterial Endotoxin (LAL), Environmental monitoring
Lead Time Band
Start in 4-8 weeks
Quote SLA
3-5 business days
Sample Return Policy
Return, Dispose, Both options
Minimum Project Size
$25-50k
Pricing Model
Per project, Fixed package, Custom
