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Non-GLP Preclinical Proof of Concept Studies for Medical Devices

Experience Matters. Why Companies Choose NAMSA.

540+

Medical Device Non-GLP Preclinical Projects Last 12 Months

4

Sites in US and Europe Offering Preclinical Ô°ÇøÒùÂÒ

20

Fully Equipped ORs and Cath Labs in US and Europe

13

Surgeons and Interventionalists on Staff

Deep Expertise in Preclinical Research for Medical Devices Under Development

Non-GLP studies at an early stage in the development process can minimize the risk of failure during GLP preclinical studies and help Sponsors decide next steps in their research, development, and testing processes.

Non-GLP proof of concept studies receive less regulatory scrutiny and do not have the same archive and report standard requirements as GLP studies, making them a cost-effective option. As a result, non-GLP studies can also be scheduled and carried out more quickly due to shorter testing durations, smaller sample sizes, and faster report delivery.

Finally, a non-GLP study can be very useful in providing important insights and data on how a device is performing in vivo—an important step before Sponsors invest in a GLP study. Pricing can be optimized if both non-GLP and GLP studies are completed at NAMSA.

Do We Have Expertise With Your Device?

Want to learn more about our preclinical experience for your specific category of device?

Explore Our Therapeutic Expertise

Numerous Models for Early Feasibility and Proof Of Concept Studies

Working in state-of-the-art laboratories, our highly-trained experts utilize a broad range of trusted in vivo models and analysis tools to deliver accelerated, cost-efficient results.

Combining decades of experience in therapy delivery systems and implantable medical device research, Ô°ÇøÒùÂÒserves as the industry’s premier destination for preclinical interventional research.

Although NAMSA’s surgical staff is equipped with all the necessary tools to support your entire procedure, we also provide individual services to support your preclinical needs. Interested in having your key opinion leader (KOL) or design team personnel work with your product? No problem. The Ô°ÇøÒùÂÒteam will fill in the necessary gaps in procedure roles so that your staff can concentrate on their duties during the implant or treatment procedure.

Ô°ÇøÒùÂÒLab Equipment and Facilities

View a list of equipment on this page.

Ô°ÇøÒùÂÒLab Equipment and Facilities

Meet Our Preclinical Experts

Explore the depth of our team’s expertise.

Meet Our Team
  • Jack Risdahl, DVM, PhD

    Jack Risdahl
    Principal Strategy Consultant, Preclinical
    View Bio
  • Gaëlle Clermont, PharmD, PhD

    Principal Strategy Consultant
    View Bio
  • Michael A. Jorgenson, BS

    Principal Interventionalist
    View Bio
  • Tyler LaMont

    Senior Interventionalist
    View Bio
  • Katie Miedtke

    Interventionalist
    View Bio
  • Corey Leet

    Director, Regional Preclinical and In-Vivo Biocompatibility Operations
    View Bio

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