Design and Prototyping
Unlocking Innovation: Revolutionize Medical Device Prototyping with Cutting-Edge 3D Printing
We understand that time is of the essence in the medical industry, where groundbreaking ideas can save lives. That’s why we offer a game-changing solution that accelerates your path from concept to reality, while ensuring precision, quality, and cost-effectiveness every step of the way.
Why choose us? Our team is a powerhouse of expertise, with a deep understanding of both medical technology and advanced 3D printing techniques. By harnessing the potential of additive manufacturing, we empower you to swiftly iterate and refine your designs, revolutionizing the prototyping process. Our cutting-edge 3D printers allow for intricate details, complex geometries, and customizability, enabling you to create medical devices that align seamlessly with your vision.
But it doesn’t stop there. We pride ourselves on our commitment to collaboration. When you partner with us, you gain access to a dedicated team of skilled professionals who will work hand-in-hand with you, providing invaluable insights and guidance. From brainstorming innovative solutions to troubleshooting design challenges, we are here to make your vision a reality. With our combined expertise, we ensure that your medical device prototypes meet the highest standards of functionality, durability, and safety.
Embrace the future of medical device prototyping. Join forces with Prime Path Medtech and harness the transformative power of 3D printing. Experience shorter lead times, enhanced design capabilities, and significant cost savings. Let’s revolutionize healthcare together, one prototype at a time.
Have an idea, however, you aren’t sure where to begin?
Schedule a complimentary 30-minute call with us get started.
Why Choose Us
ISO 13485:2016
Why not begin your journey on the best foot with a certified quality partner from the start? As a full-service manufacturing provider, we believe in quality. Being ISO 13485:2016 and FDA registered demonstrates that commitment.
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3D Printing Experts
We have been recognized by EOS as a “premier” partner in North America. EOS is the leading technology provider worldwide for industrial 3D printing of metals and plastics and offers integrated solutions in additive manufacturing.
Budget Friendly
As a small business, we understand the importance of capital preservation. We are always trying to find creative ways to keep the costs low both in prototyping and manufacturing.
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FDA SubmissionsFDA Submissions (510K, De Novos, PMAS, etc.) Our experts can develop your strategy, lead your product development team, advise and assist with your testing, write the submission, and interact with the regulatory agency at all levels to help provide the fastest clearances possible. 510K DE NOVOs PMAs
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Investigational Device ExemptionsInvestigational Device Exemptions (IDE) Clinical research studies can be a key first step in a product development and clearance pathway. Let our experts help you with the regulatory plan, the protocol development, pre-IDE meetings with the FDA and IDE submission, follow-up, and completion. We can help at any stage or any step.
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Device ClassificationDevice Classification Do you need help understanding the regulatory pathway for your idea or product? Our experts can provide guidance. Our team of Biomedical Engineers has years of experience classifying and gaining clearances around the world for thousands of devices and products.
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FDA Registration and ListingFDA Registration and Listing Not sure if you need to register with the FDA? Not sure how to register? It is not you; the FDA registration process is difficult to understand and the actual process is not clear or easy to do. Good News, we have registered all kinds of companies. We are willing to register your company with the FDA with no additional costs from us.
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Medical Device ReportingMedical Device Reporting (MDRS) Do you understand the process? Are you registered with the FDA? Do you need help understanding or executing the review of complaints? If you answered yes to any of these questions, let us help. We have experts that understand both the engineering side of the product, as well as the regulatory aspects of the situation. We can provide expert advice and/or MDR reporting if needed. We can also address worldwide reporting too.
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International Medical Device SubmissionsInternational Medical Device Submissions Wondering what the requirements for marketing your device in Thailand are? Or does Canada look like it could be a great next step for your company? We can help you tailor an international regulatory strategy as well as execute the plan.
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Clinical Evaluation ReportsClinical Evaluation Reports (CERS) As part of the new EuMDR changes, clinical evaluation reports have taken on an even more prominent role. Do you have Class I products that now need CERs? Do you have products with outdated CERs? Our team is here to assist.
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European Medical Device Regulations/CE MarkEuropean Medical Device Regulations/CE Mark (EUMDR) The changes in the European Union were both of a regulatory nature, however, it is also a significant cultural change in the way the process works. If you are looking towards European expansion, we would be happy to help.
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483’S483’S Did you just go through an FDA audit, and now you have a pile of 483’s? Do you know what to do? Do you need some extra qualified hands to get them addressed? Or do you just have questions and need some advice? Call us. We can handle all 483 questions and FDA interactions.