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) specializing in medical device and In Vitro Diagnostic (IVD) development, established in 1967. They offer comprehensive services to help companies bring innovative products to market and ensure the ongoing safety of existing ones.
**Expertise & scope**
* **Regulatory Consulting:** Expertise in US FDA submissions (510(k), De Novo, IDE, PMA), EU MDR & IVDR compliance, and global regulatory/quality assurance (QA/RA).
* **Biological Safety:** Assistance with biological evaluation plans and reports, toxicological risk assessments, and ensuring compliance with international testing requirements.
* **Market Research:** Services include go-to-market planning, commercial opportunity research, pricing strategy, and patient journey research to inform strategic decisions.
* **Preclinical Research:** Support for GLP studies, early feasibility studies, and preclinical pathology.
* **Integrated Services:** NAMSA provides a holistic view by integrating preclinical, clinical, testing, and regulatory services across the entire development spectrum.
**Reputation / proof points**
* Serves over 3,000 medical device and IVD companies worldwide annually.
* Employs a team of 1,400 specialists.
* Operates GLP-compliant and AAALAC-accredited facilities in the United States and Europe.
NAMSA is a global Contract Research Organization (CRO) specializing in medical device and In Vitro Diagnostic (IVD) development, established in 1967. They offer comprehensive services to help companies bring innovative products to market and ensure the ongoing safety of existing ones.
**Expertise & scope**
* **Regulatory Consulting:** Expertise in US FDA submissions (510(k), De Novo, IDE, PMA), EU MDR & IVDR compliance, and global regulatory/quality assurance (QA/RA).
* **Biological Safety:** Assistance with biological evaluation plans and reports, toxicological risk assessments, and ensuring compliance with international testing requirements.
* **Market Research:** Services include go-to-market planning, commercial opportunity research, pricing strategy, and patient journey research to inform strategic decisions.
* **Preclinical Research:** Support for GLP studies, early feasibility studies, and preclinical pathology.
* **Integrated Services:** NAMSA provides a holistic view by integrating preclinical, clinical, testing, and regulatory services across the entire development spectrum.
**Reputation / proof points**
* Serves over 3,000 medical device and IVD companies worldwide annually.
* Employs a team of 1,400 specialists.
* Operates GLP-compliant and AAALAC-accredited facilities in the United States and Europe.
Additional information
NAMSA's approach emphasizes a deep understanding of regulatory expectations, drawing from institutional knowledge and real-world expertise. Their consultants collaborate closely with preclinical and clinical experts to ensure submissions meet reviewer requirements. They assist in navigating complex regulatory landscapes, including the US FDA's predicate system and the EU's MDR/IVDR requirements for post-market surveillance. For market research, NAMSA leverages a vast database of contacts and in-house intellectual property to provide product-specific insights, aiding in successful product launches and repositioning.
Key Highlights
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NAMSA has been serving the medical device and IVD industries since 1967.
Source
“From startups to multinationals, NAMSA has been serving the medical device and IVD industries since 1967 and has a highly experienced team ready to serve you.”
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Employs over 1,400 specialists globally.
Source
“Our team of 1,400 specialists are ready to help you conduct market research, preclinical studies, clinical trials, biological safety testing, regulatory submissions, and much more.”
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Offers comprehensive US FDA consulting, including 510(k), De Novo, IDE, and PMA submissions.
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 EU MDR & IVDR regulatory consulting for CE Marking compliance.
Source
“We provide a wide range of regulatory strategy and consulting services related to compliance with the Medical Device Regulation (MDR 2017/745) and the In Vitro Diagnostic Regulation (IVDR 2017/746).”
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Conducts extensive medical device testing, performing over 118,000 tests in a recent year.
Source
“NAMSA conducted 118,000+ medical device tests last year so we have seen nearly every variation of device across a wide variety of therapeutic areas.”
Certifications & Trust Signals
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Operates GLP-compliant and AAALAC-accredited facilities.
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.
Source
“Our services include: ... Our dedicated team of experts, comprising seasoned medical writers and regulatory specialists, including former Notified Body staff, provides comprehensive support...”
Buyer Snapshot
Best for
- Medical device and IVD manufacturers seeking regulatory submission support.
- Companies needing assistance with EU MDR/IVDR compliance and CE marking.
- Organizations requiring market research to inform product strategy.
How engagement typically works
- Consultative approach to regulatory strategy.
- Data-driven market research insights.
- Integrated service delivery across development phases.
Typical deliverables
- Regulatory submission documentation (e.g., 510(k), PMA, Technical Files).
- Biological Evaluation Reports.
- Market research reports and go-to-market strategies.
- Post-market surveillance plans.
Good to know
- Best when requiring specialized expertise in medical device and IVD regulations.
- Ideal for companies needing a comprehensive partner from early development to market access.
HQ:
United States, US
Languages:
English
Timezones:
UTC, EST
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:
Both
Services Offered:
User interface evaluation, Instructions evaluation, Validation testing, Other
User Types Supported:
Lay user, Professional healthcare, Both
Use Environments Supported:
Home healthcare, Professional healthcare, Both
Standards Supported:
IEC 62366-1, FDA Human Factors Guidance, ISO 14971, Other
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
Additional usability_human_factors_testing Details
Usability Study Types Offered
Formative study, Summative study, Both
Services Offered
Risk analysis, Task analysis, User interface evaluation, Instructions evaluation, Validation testing, Other
Standards Supported
IEC 62366-1, IEC 62366-2, FDA Human Factors Guidance, ISO 14971, Other
User Types Supported
Lay user, Professional healthcare, Both
Use Environments Supported
Home healthcare, Professional healthcare, Both
Lead Time Band
Start in 0-2 weeks
Quote SLA
3-5 business days
Minimum Project Size
$50k+
Pricing Model
Custom
