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 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**
* Pioneer in the medical device testing industry, recognized as a global marketplace leader.
* Offers comprehensive microbiology testing services, including bacteriology, sterility testing, and bioburden analysis.
* Conducts LAL (Limulus Amebocyte Lysate) testing, also known as bacterial endotoxin testing, using Kinetic Turbidimetric and Kinetic Chromogenic methods.
* Provides extensive consulting services for US FDA and EU MDR/IVDR compliance, including 510(k) preparation, De Novo submissions, and Post-Market Surveillance (PMS) activities.
* Specializes in biological safety consulting, including toxicological risk assessment, extractables and leachables testing, and developing biological evaluation reports.
* Offers market research services for medical devices and IVDs, covering go-to-market planning, commercial opportunity research, and competitive analysis.
* Supports global regulatory and quality management system compliance, including ISO 13485 and US FDA 21 CFR Part 820.
* Operates GLP-compliant and AAALAC-accredited preclinical laboratories in the United States and Europe.
**Reputation / proof points**
* Serves over 3,000 medical device and In Vitro Diagnostic companies worldwide annually.
* Employs a team of 1,400 specialists.
* Conducts over 100,000 tests annually across its laboratories.
* Has offices in Switzerland and Sweden.
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**
* Pioneer in the medical device testing industry, recognized as a global marketplace leader.
* Offers comprehensive microbiology testing services, including bacteriology, sterility testing, and bioburden analysis.
* Conducts LAL (Limulus Amebocyte Lysate) testing, also known as bacterial endotoxin testing, using Kinetic Turbidimetric and Kinetic Chromogenic methods.
* Provides extensive consulting services for US FDA and EU MDR/IVDR compliance, including 510(k) preparation, De Novo submissions, and Post-Market Surveillance (PMS) activities.
* Specializes in biological safety consulting, including toxicological risk assessment, extractables and leachables testing, and developing biological evaluation reports.
* Offers market research services for medical devices and IVDs, covering go-to-market planning, commercial opportunity research, and competitive analysis.
* Supports global regulatory and quality management system compliance, including ISO 13485 and US FDA 21 CFR Part 820.
* Operates GLP-compliant and AAALAC-accredited preclinical laboratories in the United States and Europe.
**Reputation / proof points**
* Serves over 3,000 medical device and In Vitro Diagnostic companies worldwide annually.
* Employs a team of 1,400 specialists.
* Conducts over 100,000 tests annually across its laboratories.
* Has offices in Switzerland and Sweden.
Additional information
NAMSA's integrated approach spans the entire medical device development lifecycle, from early feasibility studies and preclinical research to clinical trials, testing, and regulatory submissions. Their team of over 1,400 specialists includes former Notified Body reviewers, toxicologists, and regulatory consultants, providing a holistic view of compliance requirements. They emphasize a strategic approach to biological safety, conducting gap analyses and developing tailored testing strategies to meet diverse international marketplace requirements. Clients can expect support in navigating complex regulatory landscapes, ensuring device safety, efficacy, and market access.
Key Highlights
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Pioneer in the medical device testing industry since 1967.
Source
“NAMSA has been serving the medical device and IVD industries since 1967”
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Conducts over 100,000 tests annually across its US and European laboratories.
Source
“Every year NAMSA laboratories in US and Europe conduct more than 100,000 tests”
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Offers comprehensive consulting for US FDA and EU MDR/IVDR 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)”
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Provides specialized biological safety consulting, including toxicological risk assessment.
Source
“Toxicological Risk Assessment This assessment evaluates the toxicity of individual chemical ingredients of the formulation used to manufacture a particular medical device.”
Certifications & Trust Signals
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Operates GLP-compliant and AAALAC-accredited preclinical laboratories.
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 toxicologists.
Source
“Our team includes former Notified Body reviewers, toxicologists, preclinical scientists, clinical specialists, and regulatory consultants.”
Buyer Snapshot
Best for
- Medical device and IVD manufacturers 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
- Project-based consulting and testing.
- Integrated service offerings across the product lifecycle.
- Strategic partnership for regulatory navigation.
Typical deliverables
- Microbiology testing reports (Bioburden, Sterility, LAL).
- Regulatory submission documentation (510(k), PMA, EU MDR/IVDR).
- Biological Evaluation Reports and Toxicological Risk Assessments.
- Market research reports and go-to-market strategies.
Good to know
- Best when engaging for complex testing and regulatory challenges.
- Ideal for companies needing global regulatory expertise.
HQ:
United States
Languages:
English
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
Additional sterilization_microbiology_testing Details
Sterilization Methods Supported
N/A
Validation Types Offered
N/A
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
N/A
Minimum Project Size
N/A
Pricing Model
Custom
