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 medical device Contract Research Organization (CRO) established in 1967, specializing in services that support clients from product concept through commercialization. They focus on ensuring the safety, efficacy, and worldwide compliance of medical devices and In Vitro Diagnostic (IVD) products.
**Expertise & scope**
* **Regulatory Consulting:** Expertise in US FDA compliance, including 510(k) submissions, De Novo pathways, Investigational Device Exemptions (IDE), and Premarket Approvals (PMA). They also provide consulting for EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746), assisting with CE Marking and Post-Market Surveillance (PMS).
* **Biological Safety:** Comprehensive consulting for biological safety, including gap analysis, toxicological risk assessments, and ensuring compliance with international marketplace requirements. This involves evaluating chemical ingredients, extractables, leachables, and degradable materials.
* **Market Research:** Services include go-to-market planning and strategy, commercial opportunity research, pricing strategy, brand and competitor research, and patient journey research, leveraging a database of contacts and intellectual property.
* **Global QA/RA Compliance:** Assistance with global regulatory and quality management system compliance, including ISO 13485 and US FDA 21 CFR Part 820, QMS audits, and risk management.
* **Preclinical & Clinical Support:** Offers preclinical laboratory support in GLP-compliant and AAALAC-accredited facilities, as well as clinical trial support.
**Reputation / proof points**
* Founded in 1967.
* Serves over 3,000 medical device and IVD companies annually.
* Employs a team of 1,400 specialists.
* Operates GLP-compliant and AAALAC-accredited facilities in the United States and Europe.
* Has conducted over 118,000 medical device tests in a single year.
NAMSA is a medical device Contract Research Organization (CRO) established in 1967, specializing in services that support clients from product concept through commercialization. They focus on ensuring the safety, efficacy, and worldwide compliance of medical devices and In Vitro Diagnostic (IVD) products.
**Expertise & scope**
* **Regulatory Consulting:** Expertise in US FDA compliance, including 510(k) submissions, De Novo pathways, Investigational Device Exemptions (IDE), and Premarket Approvals (PMA). They also provide consulting for EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746), assisting with CE Marking and Post-Market Surveillance (PMS).
* **Biological Safety:** Comprehensive consulting for biological safety, including gap analysis, toxicological risk assessments, and ensuring compliance with international marketplace requirements. This involves evaluating chemical ingredients, extractables, leachables, and degradable materials.
* **Market Research:** Services include go-to-market planning and strategy, commercial opportunity research, pricing strategy, brand and competitor research, and patient journey research, leveraging a database of contacts and intellectual property.
* **Global QA/RA Compliance:** Assistance with global regulatory and quality management system compliance, including ISO 13485 and US FDA 21 CFR Part 820, QMS audits, and risk management.
* **Preclinical & Clinical Support:** Offers preclinical laboratory support in GLP-compliant and AAALAC-accredited facilities, as well as clinical trial support.
**Reputation / proof points**
* Founded in 1967.
* Serves over 3,000 medical device and IVD companies annually.
* Employs a team of 1,400 specialists.
* Operates GLP-compliant and AAALAC-accredited facilities in the United States and Europe.
* Has conducted over 118,000 medical device tests in a single year.
Additional information
NAMSA's integrated service model allows for a holistic approach to medical device development and compliance. By combining regulatory consulting with preclinical research, clinical trials, and testing services, they aim to streamline the path to market. Their team comprises former Notified Body reviewers, toxicologists, preclinical scientists, clinical specialists, and regulatory consultants, offering deep institutional knowledge and real-world expertise. This multidisciplinary approach is designed to anticipate regulatory expectations and ensure efficient product development cycles. Clients can expect support in navigating complex regulatory landscapes across major markets like the US and EU, with a focus on balancing benefit-risk ratios and practical compliance requirements.
Key Highlights
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Founded in 1967, NAMSA has extensive experience supporting medical device and IVD industries.
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 to assist with market research, preclinical studies, clinical trials, and regulatory submissions.
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) preparation, De Novo submissions, and Premarket Approvals (PMA).
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 consulting for CE Marking, including support for Post-Market Surveillance (PMS) activities.
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 over 118,000 medical device tests annually, with expertise in biological safety and toxicological risk assessment.
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 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, toxicologists, and regulatory consultants.
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 end-to-end regulatory and compliance support.
- Companies needing assistance with US FDA submissions (510(k), PMA, De Novo) and EU MDR/IVDR compliance.
- Organizations requiring specialized biological safety assessments and toxicological risk evaluations.
- Businesses looking for market research to inform product launch or repositioning strategies.
How engagement typically works
- Consultative approach to regulatory strategy and planning.
- Collaborative development of testing and submission documentation.
- Project-based support for specific regulatory milestones.
- Long-term partnerships for ongoing compliance and market access.
Typical deliverables
- Regulatory strategy reports and roadmaps.
- Submission dossiers for FDA and EU regulatory bodies.
- Biological Evaluation Reports and toxicological risk assessments.
- Market research reports and go-to-market plans.
- Quality Management System (QMS) documentation and audit support.
Good to know
- Best when clients require specialized expertise in medical device and IVD regulations.
- Ideal for companies navigating complex international regulatory requirements.
- Suitable for projects requiring a blend of regulatory, preclinical, and market insights.
HQ:
North Canton, US
Languages:
English
Timezones:
EST
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
Shelf Life Methods Offered:
Real-time aging, Accelerated aging, Both
Distribution Tests Offered:
Vibration, Drop, Compression, Climate
Standards Supported:
ISO 11607, ASTM D4169, ISTA, ISO 16775, FDA Guidance
Is Accredited:
Yes
Accreditation Body:
AAALAC
Has Climate Chambers:
Yes
Has Distribution Simulation:
Yes
Nda Support:
Yes
Additional packaging_shelf_life_testing Details
Packaging Tests Offered
Package integrity, Seal strength, Burst strength, Compression, Vibration, Drop
Standards Supported
ISO 13485, FDA Guidance, EU MDR, IVDR
Shelf Life Methods Offered
Real-time aging, Accelerated aging
Distribution Tests Offered
Vibration, Shock, Drop, Compression, Climate
Lead Time Band
Start in 0-2 weeks
Quote SLA
24-48 hours
Sample Return Policy
Return, Dispose, Both options
Minimum Project Size
$50k+
Pricing Model
Custom
