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 leading Contract Research Organization (CRO) specializing in medical device testing, preclinical research, and regulatory consulting, serving the medical device and IVD industries since 1967. They are recognized as a global marketplace leader for trusted microbiology testing services.
**Expertise & scope**
* Pioneers in medical device testing, offering comprehensive services to ensure device safety, efficacy, and compliance worldwide.
* Expertise in microbiology testing, including bacteriology, sterility testing, and bioburden analysis to determine root causes for excursions and lower microbial contaminants.
* Specialized LAL (Limulus Amebocyte Lysate) testing, also known as bacterial endotoxin testing, utilizing Kinetic Turbidimetric and Kinetic Chromogenic methods.
* Extensive consulting services covering US FDA compliance (510(k), De Novo, PMA, QMSR audits), EU MDR & IVDR regulations, and global regulatory/quality assurance (RA/QA).
* Support for biological safety consulting, including risk assessment, gap analysis, and toxicological risk assessment for chemical ingredients.
* Preclinical research support in GLP-compliant and AAALAC-accredited facilities.
* Human factors and usability testing for medical devices.
**Reputation / proof points**
* Conducts over 100,000 tests annually across US and European laboratories.
* Employs a team of 1,400 specialists.
* Serves over 3,000 medical device and In Vitro Diagnostic companies annually.
* Has offices in the US and Europe.
NAMSA is a leading Contract Research Organization (CRO) specializing in medical device testing, preclinical research, and regulatory consulting, serving the medical device and IVD industries since 1967. They are recognized as a global marketplace leader for trusted microbiology testing services.
**Expertise & scope**
* Pioneers in medical device testing, offering comprehensive services to ensure device safety, efficacy, and compliance worldwide.
* Expertise in microbiology testing, including bacteriology, sterility testing, and bioburden analysis to determine root causes for excursions and lower microbial contaminants.
* Specialized LAL (Limulus Amebocyte Lysate) testing, also known as bacterial endotoxin testing, utilizing Kinetic Turbidimetric and Kinetic Chromogenic methods.
* Extensive consulting services covering US FDA compliance (510(k), De Novo, PMA, QMSR audits), EU MDR & IVDR regulations, and global regulatory/quality assurance (RA/QA).
* Support for biological safety consulting, including risk assessment, gap analysis, and toxicological risk assessment for chemical ingredients.
* Preclinical research support in GLP-compliant and AAALAC-accredited facilities.
* Human factors and usability testing for medical devices.
**Reputation / proof points**
* Conducts over 100,000 tests annually across US and European laboratories.
* Employs a team of 1,400 specialists.
* Serves over 3,000 medical device and In Vitro Diagnostic companies annually.
* Has offices in the US and Europe.
Additional information
NAMSA emphasizes an integrated approach, combining their deep understanding of regulatory expectations with extensive preclinical and clinical expertise. This allows them to provide a holistic view of product development requirements, ensuring compliance with global regulations such as FDA and EU MDR/IVDR. They assist clients in navigating complex regulatory landscapes, from initial strategy and testing to post-market surveillance. Their services are designed to accelerate project timelines and deliver expert results recognized by regulatory authorities.
Key Highlights
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NAMSA is a pioneer and global marketplace leader in medical device testing, serving the industry since 1967.
Source
“NAMSA is the pioneer of the medical device testing industry and continues to serve as the global marketplace leader for trusted microbiology testing services.”
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Conducts over 100,000 medical device tests annually in its US and European laboratories.
Source
“Every year NAMSA laboratories in US and Europe conduct more than 100,000 tests measuring biocompatibility, package integrity, microbiology, and sterility.”
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Offers comprehensive consulting for US FDA and EU MDR/IVDR regulations, including submissions and post-market compliance.
Source
“NAMSA can assist with a wide range of FDA compliance support including 510(k) preparation, De Novo submissions, Investigational Device Exemptions, Premarket Approvals (PMA), combination drug-device products, QMSR audits, and more.”
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Provides specialized LAL (bacterial endotoxin) testing using Kinetic Turbidimetric and Kinetic Chromogenic methods.
Source
“The LAL test includes the Kinetic Turbidimetric, and Kinetic Chromogenic methods, each offering high sensitivity and regulatory compliance.”
Certifications & Trust Signals
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Operates GLP-compliant and AAALAC-accredited facilities in the United States and Europe for preclinical research.
Source
“Unparalleled preclinical laboratory support for sponsors at GLP-compliant and AAALAC-accredited facilities in the United States and Europe.”
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Team includes former Notified Body reviewers and regulatory specialists with deep clinical expertise.
Source
“Our services include: NAMSA’s dedicated team of experts, comprising seasoned medical writers and regulatory specialists, including former Notified Body staff, provides comprehensive support in developing and executing effective PMS activities.”
Buyer Snapshot
Best for
- Medical device and IVD companies seeking comprehensive testing and regulatory support.
- Companies needing assistance with US FDA and EU MDR/IVDR compliance.
- Organizations requiring specialized microbiology and biological safety testing.
How engagement typically works
- Collaborative consulting and strategy development.
- Project-based testing and research services.
- Integrated support across the entire product development lifecycle.
Typical deliverables
- Microbiology testing reports (Bioburden, Sterility, LAL).
- Regulatory submission documentation (510(k), PMA, MDR/IVDR dossiers).
- Biological evaluation reports and risk assessments.
- Preclinical study reports.
- Human factors and usability study reports.
Good to know
- Best when clients require specialized expertise in medical device compliance and testing.
- Ideal for companies navigating complex global regulatory requirements.
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, Environmental monitoring
Is Accredited:
Yes
GMP Compliant:
No
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:
Other
Quote SLA:
3-5 business days
Additional sterilization_microbiology_testing Details
Sterilization Methods Supported
N/A
Validation Types Offered
N/A
Microbiology Tests Offered
Bioburden, Sterility, Bacterial Endotoxin (LAL)
Lead Time Band
Start in 4-8 weeks
Quote SLA
3-5 business days
Sample Return Policy
N/A
Minimum Project Size
N/A
Pricing Model
Per project
