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Medical Device Regulation Specialist

Medical Device Experts

Get expert advice for every step of your journey in bringing your medical device to market. Our engagement models range from full-service, individual, or customized services across Strategy, Regulatory, Clinical, Quality and Training areas of focus.

About Us

An outcome-driven partner with a value-based model

We partner with small and mid sized companies at all stages to achieve business outcomes – from strategic regulatory planning to all phases of the product development process to get your product on the market. Our primary areas of focus are services in product development, regulatory, quality, and clinical research.

Our experience on multiple successful deployments helps us predict needs and anticipate challenges for our clients. The “shared services” model provides broad, in-depth and up-to-date expertise on-demand at a fraction of the cost of having in-house full time resources.

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Our Services

We know your business and we would love to be a more integrated part of it.

Regulatory

We provide everything from full-service domestic and international submissions to daily regulatory tasks.
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Quality

We have proven procedures and processes that we utilize to form the foundation of your quality system.
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Clinical Research

We are able to handle all aspects of your clinical research programs, or supplement your in-house teams as needed.
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Prototyping & Design

We offer full-service design, strategic planning, and prototyping services.
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QSuite

QSuite is an affordable eQMS system. It is designed for small to mid sized businesses.
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Training

Whatever you need, we can work with your team to create a web-based training for your team.
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eLearning

We have an in-house team of eLearning experts and established resources that can create engaging, interactive content to bring your training to life.
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Content Experts

We have content experts in Regulatory, Quality, Product Development, and Clinical Research.
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We offer training for you and your team

Complaint Training

One of the most frequent FDA findings is an organization’s failure to handle complaints correctly and timely. This course provides your entire organization a quick and effective reminder of the importance of reporting complaints promptly. This is a practical training designed to engage, reinforce, and help the whole team understand the importance of complaint handling.

30 minutes; self-paced; final assessment with a certificate upon passing.

Measurement and Calibration

What every manager, engineer, and technician needs to know about measurements and calibration of systems. How do you know if your system has the right capability, traceability, and stability? What needs to be calibrated? How often? Best methods? Standards?

Expert Instructor led. Over 20+ years of experience with medical device systems. Get your specific questions addressed in class.

4-hour webinar; final assessment with a certificate upon passing.

Quality Systems Training (FDA 21CFR820 and ISO 13485:2016)

Designed for both individuals and quality teams working in the medical device field, this course covers every aspect of essential standards and presents users with case studies and effective solutions. This training provides a solid foundation to build a better understanding why each regulation exists. We know that discussing the whys and hows of requirements provides actual value, that is why this training is much more than just “here are the rules, learn them.” Our team assumes you can read.

In addition, this class has “office hours,” where attendees can discuss specific questions in confidence with a medical device quality expert.

8 to 12 hours; self-paced; final assessment with a certificate upon passing.

ISO 13485:2016 Lead Auditor Course

Perfect for any individual in the medical device field, this comprehensive training covers every element of conducting an audit, case studies, and real-world solutions. This course will provide you with extensive knowledge and auditing experience.

“Office hours” are also offered for attendees to discuss questions in confidence with a certified auditor during and after the course. Additionally, there will be a live assessment by a Certified Auditor as part of the final assessment.

16-20 hours; self-paced; final assessment with a certificate upon passing.

Good Clinical Practices (GCP)

Geared towards individuals in the medical device field, especially those in clinical research, this course covers all clinical research standards: FDA regulations (IDE, IRBs, etc.), ICH E6, and other international standards. You will be presented with case studies and effective, practical solutions. Providing a comprehensive background and discussing real world implications will build a better understanding as to why each regulation exists. We know that discussing the whys and hows of requirements provides actual value, that is why this training is much more than just “here are the rules, learn them.” Our team assumes you can read.

In addition, this class has “office hours,” where attendees can discuss specific questions in confidence with a medical device Clinical/Regulatory Expert.

8 to 12 hours; self-paced; final assessment with a certificate upon passing.

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What Our Clients Say

“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.”

Ren Menon

CEO, Ortho FX
Chris Martinez - CEO - 3DPX

Prime Path Medtech’s vast industry knowledge and years of experience gives us the confidence we need when working with strict regulatory agencies.

They seamlessly worked with our team members from engineering to production to design to ensure we had the right quality systems in place. They treat us a partner and truly believe that our success is their success.

As we continue to take on new endeavors we will make sure to have the team at Prime Path Medtech with us every step of the way.

Chris Martinez

CEO, 3DPX
Catherine Varley - CEO - MumEase

The Prime Path Medtech team are experts in the industry and really care about the companies that they work with.  They are problem solvers and will work with you from start to finish to get results.

The breadth and depth of Bill’s industry knowledge has been hugely valuable to my company over the last year. ​

Choosing to work with Prime Path Medtech is choosing to have the best people in your corner.  I highly recommend them-you will not find a better group of people to work with.

Catherine Varley

CEO, MumEase
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Have questions on what Prime Path Medtech can do for you?

Blog
February 3, 2021

DHR vs DMR vs DHF

In the medical device industry, DHR, DMR and DHF are three integral cornerstones of the design control process.…

FDA Regulations
February 3, 2021

Is your product a medical device?

Are you unsure if your product is a medical device? From an adult diaper to an MRI machine,…

MDSAP
February 3, 2021

What is MDSAP?

The Medical Device Single Audit Program (MDSAP) allows a single regularity audit of a medical device manufacturer’s quality…