top of page
smiling female doctor walking with patients

Regulatory - Quality - Clinical Research (CRO)

Proven Partner for
Medical Device Innovators

STAND-ALONE SERVICES

If you know exactly what service you are looking for and just need some additional details, this is the place for you.

ENTREPRENEUR

Are you an ambitious entrepreneur with a brilliant idea that’s itching to take the world by storm? Look no further!

FRACTIONAL STAFFING

Instead of hiring one or two individuals, you can hire an entire team of experts – fractionally.

Our engagement models cover full-service medical device consulting for Strategy, Regulatory Devices, Clinical Evaluations, Quality Standards (ISO), and Project Management areas of focus

Flag on Mountain Peak

01

Expert Problem Solvers

Our team is medical device engineers by degree and training. Like skilled artisans, engineers craft elegant solutions, seamlessly blending practicality with brilliance, leaving no problem unsolved.

02

Budget Friendly

A fully Remote Workforce keeps our infrastructure price low and we pass on the savings to you. We offer Fractional Staffing, so you get the expertise you need at a price that you want.

03

Low Turnover

Our team has industry-leading low turnover rates. Your project leader will be there from the start of the project until you cross the finish line.

Why Choose Us

04

Fractional Staffing

We leverage our experience and talent to deliver a top-notch team that saves you time and money compared to the cost of a “full time” team.

05

Best In-Class Technology

We are preferred partners with a best-in-class EDC system (Viedoc), bringing the benefits of a world-class EDC system with a lower price point to your project.

06

24/7 Service

We know that clinical studies are unpredictable and emergencies are part of the job, so our project managers are committed to providing assistance 24/7.

Client Testimonials

"What makes Prime Path Medtech truly exceptional is their business thinking mindset. Prime Path Medtech works as your true partner, takes interest in your business objectives and finds the right solutions for your needs.

 

​I have lost count of the times Prime Path Medtech’s counsel was invaluable. Especially, when working with start-up ventures. If there is such a thing as a resounding endorsement, look no further, this is it."

Ortho FX

Ren Menon

Contact

How to Submit a 510k to the FDA

Submitting a 510(k) doesn’t have to be overwhelming. Let us walk you through the process step-by-step so you can focus on getting your product to market faster!

Watch New Videos Here:

Check out our new videos on everything about medical device + FDA approval!

If you're in the *medical device industry* and need to submit a 510(k), this video is for you!

 

In this video, you'll learn: 

  • What a 510(k) submission is

  • Key information you need before submitting

  • How to submit your 510(k) using the FDA's new eSTAR system

  • What happens after you submit and how to handle RTA holds

  • How to get that all-important 510(k) decision letter

Winding Roads

About Prime Path Medtech™

Prime Path Medtech™ is a leading medical device consulting firm specializing in regulatory and compliance solutions tailored to the unique needs of medical innovators. With a focus on medical device development and product development processes, we offer a balanced approach that aligns FDA cleared vs. approved requirements with your business objectives, ensuring both regulatory compliance and operational efficiency.

​

Our team of expert medical device consultants and regulatory professionals brings a wealth of experience in navigating complex regulatory environments, including ISO standards for medical devices, FDA audits, and clinical evaluations. We understand that each client’s journey is unique, which is why our fractional staffing model provides flexibility and cost-effectiveness without compromising on quality.

​

At Prime Path Medtech™, we partner with innovators who are driven to improve lives through their products. Our clinical research consulting services support clients from early medical device product development to market launch, allowing for seamless integration into both regulatory and commercial strategies. Together, we navigate the regulatory landscape to achieve clinical research prime and optimal business outcomes, ensuring that every step of the journey meets your business goals and compliance needs.

Looking for a partner

Thanks for submitting!

bottom of page