NAMSA
★★★★★
3.5
/ 5
•
16 reviews
NAMSA is a leading global CRO specializing in medical device and IVD development, offering comprehensive services from preclinical research to regulatory submissions and market access.
NAMSA is a premier global Contract Research Organization (CRO) dedicated to advancing medical device and In Vitro Diagnostic (IVD) innovation and safety worldwide. With over 50 years of experience, NAMSA supports over 3,000 companies annually, from startups to multinationals, in navigating the complex regulatory landscape. Their extensive expertise covers the entire product lifecycle, including strategic consulting, preclinical research, clinical trials, biological safety testing, and market access. Leveraging a team of 1,400+ professionals across North America, Europe, and Asia, NAMSA provides unparalleled support for regulatory submissions to agencies like the US FDA and EU Notified Bodies. They offer specialized services such as US FDA consulting (510(k), PMA, De Novo), EU MDR & IVDR consulting, biological safety assessments, and market research. Their state-of-the-art, GLP-compliant facilities conduct over 118,000 tests annually, ensuring devices are safe, effective, and compliant with global regulations. NAMSA's integrated approach ensures clients receive tailored solutions, from initial concept to commercialization. They are committed to helping clients shorten time-to-market, reduce costs, and achieve successful product launches by providing deep industry knowledge and client-focused service.
About
**Who they are**
NAMSA is a global Contract Research Organization (CRO) focused on medical device and In Vitro Diagnostic (IVD) development. They offer a comprehensive suite of services designed to support clients throughout the entire product lifecycle.
**Expertise & scope**
* Specializes in medical device and IVD development.
* Services span preclinical research, regulatory submissions, and market access.
* Focuses on Usability / Human Factors Engineering.
**Reputation / proof points**
* Leading global CRO.
NAMSA is a global Contract Research Organization (CRO) focused on medical device and In Vitro Diagnostic (IVD) development. They offer a comprehensive suite of services designed to support clients throughout the entire product lifecycle.
**Expertise & scope**
* Specializes in medical device and IVD development.
* Services span preclinical research, regulatory submissions, and market access.
* Focuses on Usability / Human Factors Engineering.
**Reputation / proof points**
* Leading global CRO.
Additional information
NAMSA's approach to Usability / Human Factors Engineering is integrated into the broader medical device development process. Buyers can expect a structured engagement that moves from initial research through to regulatory compliance and market entry. The firm's expertise in navigating complex regulatory landscapes is a key consideration for companies seeking to bring innovative medical technologies to market efficiently and safely. Their comprehensive service model aims to streamline the development pathway, reducing potential delays and ensuring adherence to global standards.
Key Highlights
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Global CRO specializing in medical device and IVD development.
Source
“NAMSA is a leading global CRO specializing in medical device and IVD development”
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Offers comprehensive services from preclinical research to regulatory submissions and market access.
Source
“offering comprehensive services from preclinical research to regulatory submissions and market access.”
Certifications & Trust Signals
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Leading global CRO.
Source
“NAMSA is a leading global CRO”
Buyer Snapshot
Best for
- Medical device and IVD developers
- Companies seeking end-to-end development support
How engagement typically works
- Comprehensive service offering
- Regulatory submission support
Typical deliverables
- Preclinical research reports
- Regulatory submission documentation
- Market access strategies
Good to know
- Best when requiring specialized Usability / Human Factors Engineering expertise within a broader development context.
HQ:
United States, US
Languages:
English
Timezones:
UTC, EST
Claim status:
Listed
Services & Capabilities
Usability / Human Factors Testing
Countries:
United States, United Kingdom, Switzerland, Canada, Japan, Australia, Brazil, Europe, Asia
Industries:
Medical Devices
Pricing model:
Custom pricing
Usability Study Types Offered:
Formative study, Summative study
Services Offered:
Task analysis, User interface evaluation, Instructions evaluation, Validation testing
User Types Supported:
Lay user, Professional healthcare
Use Environments Supported:
Home healthcare, Professional healthcare
Standards Supported:
IEC 62366-1, FDA Human Factors Guidance
Has Participant Recruitment:
Yes
Has Usability Lab:
Yes
Has Remote Testing:
Yes
Is Accredited:
Yes
Accreditation Body:
AAALAC
Rush Available:
Yes
Nda Support:
Yes
Regions Served:
North America, Europe, Asia
Minimum Project Size:
No minimum
Lead Time Band:
Start in 0-2 weeks
Quote SLA:
24-48 hours
Additional usability_human_factors_testing Details
Usability Study Types Offered
Both
Services Offered
Risk analysis, Task analysis, User interface evaluation, Instructions evaluation, Validation testing
Standards Supported
IEC 62366-1, FDA Human Factors Guidance
User Types Supported
Both
Use Environments Supported
Both
Lead Time Band
Start in 4-8 weeks
Quote SLA
3-5 business days
Minimum Project Size
Custom
Pricing Model
Custom
