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NAMSA

Helping medical device Sponsors improve healthcare since 1967, NAMSA is the world’s leading MedTec Learn more: https://namsa.com/about/client-testimonials/

Helping medical device Sponsors improve healthcare since 1967, NAMSA is the world’s leading MedTech Contract Research Organization (CRO) offering global end-to-end development services. Driven by its global regulatory expertise and in-depth therapeutic knowledge, NAMSA is dedicated to accelerating medical device product development, offering only the most proven solutions to move clients’ products through the development lifecycle efficiently and cost-effectively. From medical device testing; regulatory, reimbursement and quality consulting; and clinical research services, NAMSA is the industry’s premier, trusted partner for successful development and commercialization outcomes.

03/17/2025

Having the right medical device regulatory consulting partner at the right time can be invaluable in attaining compliance and market access.

NAMSA is the industry leader in driving successful medical device and IVD regulatory submissions/outcomes through:

-Effective, daily interactions with the U.S. FDA, Japan's PMDA, Europe's Notified Bodies, China's NMPA and other international authorities
-On-demand external support and expertise-many of our Associates have previously held positions with regulatory bodies, which provides you the benefit of a clear understanding on how to proactively plan for international requirements and expectations
-Developing and implementing global regulatory strategies to accelerate your specific commercialization efforts

Whether the goal is to extend your in-house capabilities or obtain access to the specialized expertise you need, our medical device regulatory consulting team can support. Learn more by visiting https://namsa.com/services/regulatory/

06/03/2024

The successful market entry of an device involves navigating complicated regulatory challenges and ensuring effective market strategies. Our dedicated in vitro diagnostics team take the guesswork out of IVD clinical research and regulatory compliance. Whether it's supporting regulatory assessments and submissions, developing IVDR-complaint , designing and managing global trials or building 2016 complaint quality systems, we've got you covered! Get in touch with our expert team today https://namsa.com/locations-contact/

10/25/2023

Thank you all for your continued support and engagement! We appreciate each and every one of our followers.

We invite you to follow our LinkedIn Page for the latest updates and information.

Stay connected: https://www.linkedin.com/company/namsa_2

Thank you once again for being part of our community. We look forward to connecting with you on LinkedIn.

10/23/2023

🎙️ In episode 7 of NAMSA's RAQA Café Podcast, we dive deep into the European Union (EU) In Vitro Diagnostic Regulation (IVDR). Join us as we sit down with Warren Jameson, NAMSA's Senior Manager of Regulatory and Quality, to explore the key aspects of IVDR 2017/746. We discuss the major changes compared to the EU's In Vitro Diagnostic Directive (IVDD), the impact on businesses of all sizes, and whether there has been a shift in the time it takes to get IVDs to market in the EU. Don't miss out on this insightful conversation, listen now: https://namsa.com/resources/podcasts-and-videos/ra-qa-cafe/the-eu-ivdr-what-do-you-need-to-know

10/19/2023

Check out our latest blog post on taking a medical device from initial idea to finalized product. It's a challenging process, but with the right help, it becomes much easier to understand. The blog covers important steps like understanding market competition, classifying your device correctly, conducting necessary testing and navigating premarket submissions. Don't miss out on valuable insights and tips for successful medical device commercialization https://namsa.com/medical-device-commercialization-process

10/13/2023

📣Engaging a CRO to complete your clinical trial can be overwhelming. Finding the right expertise and commitment is crucial. NAMSA, the largest CRO fully dedicated to medical devices and IVD, offers comprehensive clinical trial services. With over 1,500 trials supported, we have the knowledge and experience to develop a complete trial for your device or collaborate with your existing teams.

Our services include:
✔️Protocol Development
✔️Trial Site Cost Estimates
✔️Biostatistics
✔️Data Management
✔️Database Development
✔️Study Management
✔️Site Management & Monitoring
✔️Imaging Core Lab
✔️Safety

👉Contact our team today to discover how we can assist you with your clinical trial.

10/10/2023

The long-awaited ANSI/AAMI ST98 standard provides much-needed clarity on cleaning validations for reusable medical devices, serving as a crucial regulatory guideline for device manufacturers and supporting them in their regulatory submissions. With the previous standard not recognized by the FDA for several years, and a lack of ISO referencing in FDA guidance, the situation was complicated for manufacturers. But now, with the publication of ANSI/AAMI ST98, cleaning validations have their own specific guideline. At NAMSA, we understand the importance of complying with these standards, and our world-class CRO testing capabilities and experienced team are here to support you. Read the full blog post now: https://namsa.com/ansi-aami-st98-a-guideline-for-cleaning-validations-of-reusable-devices/

10/09/2023

Join NAMSA at La rentrée du DM, located in Besançon, France 🇫🇷. This two-day conference brings together experts from Notified Bodies, MedTech manufacturers, and service providers to share best practices and network. With 30+ exhibitors and conferences on clinical evaluation and technical documentation, La rentrée des DM is a key event for medical industry experts.

📅NAMSA EDUCATIONAL SESSION
Dispositifs WET: Construire un Argumentaire / Approche Réglementaire et Clinique by Thomas Miramond; Senior Regulatory Consultant, 10 October | 10:00 – 10:30 CEST

👉NAMSA's MedTech experts will be available at Booth #1 for complimentary consultations. We hope to see you there!

10/09/2023

Are you seeking a preclinical interventional and surgical laboratory with the experience, expertise, and cutting-edge equipment to conduct your medical device research efficiently and effectively? At NAMSA we are here to help ensure your success, with four global, state-of-the-art preclinical interventional and surgical facilities, NAMSA has the capabilities and experience to ensure the highest level of research success for your unique medical device testing requirements. Learn more about all of NAMSA's preclinical capabilities: https://namsa.com/services/preclinical-research/

Contact us today to learn how NAMSA can support your preclinical interventional and surgical program.

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Monday	8am - 5pm
Tuesday	8am - 5pm
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Thursday	8am - 5pm
Friday	8am - 5pm

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http://www.namsa.com/

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