NAMSA
★★★★★
3.5
/ 5
•
16 reviews
NAMSA is a leading medical device Contract Research Organization (CRO) offering comprehensive testing, preclinical research, clinical trials, and regulatory consulting services. They support clients from concept to commercialization, ensuring device safety, efficacy, and compliance worldwide.
NAMSA is a premier Contract Research Organization (CRO) dedicated to advancing medical device innovation and safety globally. With over 50 years of experience, NAMSA provides unparalleled expertise in medical device testing, preclinical research, clinical trials, and regulatory consulting. Their services encompass a wide range, including US FDA and EU MDR/IVDR consulting, biological safety assessments, and market research. NAMSA's team of over 1,400 professionals operates in state-of-the-art GLP-compliant and AAALAC-accredited facilities across North America, Europe, and Asia. They have supported over 3,000 medical device and IVD companies annually, from startups to multinationals, helping them navigate complex regulatory landscapes and shorten time-to-market. NAMSA's commitment to client success is evident in their deep industry knowledge and client-centric approach. They offer strategic guidance for regulatory submissions, QMS compliance, and post-market support, ensuring devices meet the highest standards of patient and user safety. Whether it's conducting over 100,000 medical device tests annually or providing expert consultation on complex submissions, NAMSA is the trusted partner for medical device and IVD manufacturers worldwide.
About
**Who they are**
NAMSA is a leading medical device Contract Research Organization (CRO) that provides comprehensive testing, preclinical research, clinical trials, and regulatory consulting services. They support clients from the initial concept through to commercialization.
**Expertise & scope**
* Offers extensive packaging and shelf-life testing services.
* Provides preclinical research and clinical trial support.
* Delivers regulatory consulting to ensure device safety, efficacy, and worldwide compliance.
**Reputation / proof points**
* Supports clients from concept to commercialization.
NAMSA is a leading medical device Contract Research Organization (CRO) that provides comprehensive testing, preclinical research, clinical trials, and regulatory consulting services. They support clients from the initial concept through to commercialization.
**Expertise & scope**
* Offers extensive packaging and shelf-life testing services.
* Provides preclinical research and clinical trial support.
* Delivers regulatory consulting to ensure device safety, efficacy, and worldwide compliance.
**Reputation / proof points**
* Supports clients from concept to commercialization.
Additional information
NAMSA's comprehensive approach to medical device development ensures that products meet rigorous safety, efficacy, and compliance standards required for global markets. Their services are designed to streamline the path to market, offering a single point of contact for a wide range of regulatory and testing needs. Buyers can expect a partner dedicated to navigating complex regulatory landscapes and validating device performance through robust scientific methods.
Key Highlights
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Leading medical device Contract Research Organization (CRO).
Source
“NAMSA is a leading medical device Contract Research Organization (CRO)”
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Offers comprehensive testing, preclinical research, clinical trials, and regulatory consulting.
Source
“offering comprehensive testing, preclinical research, clinical trials, and regulatory consulting services.”
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Supports clients from concept to commercialization.
Source
“They support clients from concept to commercialization”
Certifications & Trust Signals
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Ensures device safety, efficacy, and compliance worldwide.
Source
“ensuring device safety, efficacy, and compliance worldwide.”
Buyer Snapshot
Best for
- Medical device companies seeking end-to-end development support
- Organizations requiring specialized packaging and shelf-life testing
- Clients needing regulatory guidance for global market access
How engagement typically works
- Collaborative partnership from concept to commercialization
- Integrated testing, research, and consulting services
Typical deliverables
- Comprehensive testing reports
- Preclinical research data
- Clinical trial management
- Regulatory submission support
Good to know
- Best when requiring a full-service CRO for medical device development and compliance.
HQ:
North Canton, US
Languages:
English
Timezones:
EST
Claim status:
Listed
Services & Capabilities
Packaging + Shelf-life + Distribution Testing
Countries:
United States, United Kingdom, Switzerland, Canada, Japan, Australia, Brazil, Europe, Asia
Industries:
Medical Devices
Pricing model:
Custom pricing
Packaging Tests Offered:
Package integrity, Seal strength, Burst strength, Compression, Vibration, Drop, Other
Shelf Life Methods Offered:
Real-time aging, Accelerated aging, Both
Distribution Tests Offered:
Vibration, Drop, Compression, Climate, Other
Standards Supported:
ISO 13485, FDA Guidance
Is Accredited:
Yes
Accreditation Body:
AAALAC
Has Climate Chambers:
Yes
Has Distribution Simulation:
Yes
Nda Support:
Yes
Rush Available:
No
Minimum Project Size:
$50k+
Regions Served:
North America, Europe, Asia
Lead Time Band:
Start in 0-2 weeks
Quote SLA:
< 24 hours
Sample Return Policy:
Return
Additional packaging_shelf_life_testing Details
Packaging Tests Offered
Package integrity, Seal strength, Burst strength, Compression, Vibration, Drop
Standards Supported
ISO 11607, ASTM D4169, ISTA, ISO 16775, ISO 13485, FDA Guidance
Shelf Life Methods Offered
Real-time aging, Accelerated aging
Distribution Tests Offered
Vibration, Shock, Drop, Compression, Stacking, Climate
Lead Time Band
Start in 4-8 weeks
Quote SLA
3-5 business days
Sample Return Policy
Return
Minimum Project Size
$25-50k
Pricing Model
Per project
