Prime Path Medtech

08/26/2025

Myth Vs. Fact 🧪⭐

08/21/2025

Whether you're starting preclinical studies or preparing pivotal trials, Prime Path Medtech's Clinical Research team delivers full-service support tailored to your medical device.
Our experienced team helps you collect quality data efficiently, so your device's safety and effectiveness stand strong before FDA or global submissions.
Learn more by visiting our website: https://www.primepathmedtech.com/clinical-research

08/13/2025

Who benefits most from a fractional regulatory team?
Startups. Small and medium device firms. Global companies testing US markets. We tailor support to your phase & budget.

⭐Learn more here: primepathmedtech.com

08/04/2025

FDA audits coming up? Our certified auditors ensure you're prepared – here's how we help.
For more information: https://www.primepathmedtech.com/quality-system-auditing-services

07/30/2025

Ready to get your device to market with confidence? 🌟
Prime Path Medtech helps you navigate regulatory pathways with ease. Let's talk!

07/21/2025

What is a 510k? How do I submit one? Check out our educational resources here:
https://youtu.be/0CrtB8E2n30?si=CsTUBsnH_nb2dKXm

04/28/2025

🚀 Launching a medical device start-up? You're not alone — but success takes more than just a great idea.

From navigating regulatory hurdles to securing strong IP and clinical proof, early planning is critical.

At Prime Path Medtech, we help innovators turn groundbreaking concepts into approved, market-ready solutions.

Learn more about how we support medical device start-ups ➡️ www.primepathmedtech.com

Prime Path MedTech offers a multitude of services, including 510k consulting, FDA consulting, Clinical Research Organization (CRO) services, Medical Device Quality System support, and ISO 13485 consulting. Our team is backed by some of the brightest and most talented individuals in the industry.

04/25/2025

🚀 Looking for a CRO that truly understands medtech?

At Prime Path MedTech™, we're not your typical clinical research organization. Our team of 100% engineers brings deep expertise in devices, regulations, and real-world challenges—making us the go-to partner for medtech startups. We deliver efficient, high-quality clinical trials at a fraction of traditional CRO costs.

🔍 Clinical Trials Engineered for Results.
💡 Tailored for Startups.
💻 Learn more: www.primepathmedtech.com

Collectively, our team has worked on over 30 clinical studies ranging from Pre-Market, IDE, Pivotal, and Post Market (Registry) studies in the US and around the world.

03/27/2025

At Prime Path MedTech, we’re redefining the Clinical Research Organization (CRO) model. 🚀 Our team of engineers designs high-quality, efficient clinical trials tailored for startups—at a fraction of traditional costs.

🔬 Precision-driven research
💡 Regulatory expertise
⚡ Startup-friendly efficiency

We make clinical trials work smarter, not harder. Learn more today at https://www.primepathmedtech.com/clinical-research

Prime Path MedTech offers a multitude of services, including 510k consulting, FDA consulting, Clinical Research Organization (CRO) services, Medical Device Quality System support, and ISO 13485 consulting. Our team is backed by some of the brightest and most talented individuals in the industry.

03/06/2025

In our new YouTube video, we break down the best strategies for selecting a predicate device, including how to find similar devices, key selection criteria, and how to establish substantial equivalence to ensure a smooth FDA review process.

Learn how to:
✅ Use the FDA’s 510(k) database to find comparable devices
✅ Select a recently cleared predicate with recognized testing methods
✅ Avoid devices with safety concerns or recalls
✅ Properly demonstrate substantial equivalence in your submission

Need expert guidance on your 510(k) submission? Let us help you navigate the regulatory landscape with confidence.

🔗 Learn more at https://www.youtube.com/watch?v=qpugjVCPS44

Choosing the right predicate device is one of the most crucial steps in a 510(k) submission to the FDA. In this video, we break down the best strategies for ...

02/20/2025

🐾 The Future of Pet Healthcare is Here! 🐾

From smart collars to custom prosthetics and advanced imaging, medical devices are revolutionizing veterinary care. As pet owners continue to prioritize their furry companions’ health, innovative technologies are ensuring longer, healthier lives for our beloved animals.

🏥🐶🐱 Discover how the latest advancements in veterinary medical devices are shaping the future of pet healthcare: https://www.primepathmedtech.com/med-tech-start-articles/pawsitive-progress%3A-medical-devices-for-pets

02/18/2025

Telemedicine is evolving rapidly, thanks to AI and IoT-powered medical devices! 🌍💡

From wearable ECG monitors to smart insulin pens, these innovations enable real-time monitoring, remote diagnosis, and personalized care—making healthcare more efficient and accessible.

As technology continues to shape the future of medicine, connected devices are revolutionizing patient care. Click on the link for more information: https://www.primepathmedtech.com/med-tech-start-articles/revolutionizing-remote-care%3A-how-medical-devices-are-powering-telemedicine