INDUSTRY: MedTech

The Preferred MedTech Partner

Find out why device, diagnostic and digital therapeutic companies
made Proxima one of the fastest growing CROs in the world
200
+
medtech
Clients
65
+
medtech
Submissions
30
+
medtech Therapeutic & Industry Segments

Speed-to-market

MedTech moves 5x faster than drug development.
Partner with a CRO that can keep up.
Proxima Clinical Research moves quickly & works closely with innovators like you.

Our team has worked on hundreds of medical devices, diagnostics, and digital health products that require market approvals. Our experts have extensive experience across therapeutic areas & getting your product to market swiftly.

Our Medtech services

Build your regulatory framework unique to your device to ensure safety and efficacy while minimizing the impact on the market.
Design your product with the end-user in mind – but let us do the heavy lifting for you so you have all the research you need to make the right decisions for your patients.
Swiftly put together a plan of action united behind the medical device regulations and requirements imperative for your innovation to observe. Strategize regulatory requirements efficiently with a gap analysis that strengthens your compliance.
De-risk your device with an airtight reimbursement strategy with a comprehensive knowledge of reimbursement policies, market dynamics, and clinical considerations suited to fit your needs.
Gather your clinical study data is in the right place so it’s readily available whenever you need it to support the critical milestones of regulatory approval, reimbursement, and product marketing claims.
You know your device needs a QMS, but where do you start? Let us help you develop and implement the quality procedures you need as soon as possible.
Trust critical components for obtaining regulatory approval to market your device with the experts. You need someone who understands your device capabilities and can navigate smoothly through the complex process of developing a technical file or dossier.
Choose a knowledgeable regulatory expert to be an of your team that can be trusted with securing market access, is a clear communicator with regulatory authorities, and is a reliable resource for your medical device registrations.
You need a proactive process in place to detect and evaluate the effectiveness and safety of your device after it’s on the market. Develop a post-market surveillance program that works closely with regulatory authorities to ensure compliance with all regulatory requirements.
Quickly move your current innovation beyond its initial intended use with a team that is quick and experienced with adding new indications, expanding patient populations, or use environments with the proper data or evidence to bring before regulatory entities.

Our Medtech services

Market analysis
Create a customized regulatory framework for your medical device, ensuring safety and efficacy, while minimizing the impact on the market.
Quality management
Begin building your device's Quality Management System (QMS) with our expert guidance. We'll assist you in efficiently developing and implementing the required quality procedures.
Human factors, research & design
Design your product with the end-user in mind, and rely on our expertise to provide you with comprehensive research for informed decision-making in patient care.
Technical file & dossier development
Trust our experts to secure regulatory approval for marketing your device. With in-depth knowledge of your device's capabilities, we navigate the complex process of developing a technical file or dossier seamlessly.
Regulatory strategy & gap analysis
Create an action plan aligned with essential medical device regulations and requirements. Strengthen your compliance by strategically analyzing any gaps in regulatory requirements.
In-country representation
Work with our trusted regulatory experts to ensure market access, effectively communicate with regulatory authorities, and provide reliable support for your medical device registrations.
Reimbursement planning
De-risk your device with an airtight reimbursement strategy that takes into account policies, market trends, and clinical factors, tailored to your needs.
Post-market
Create and implement a proactive post-market surveillance program to assess the effectiveness and safety of your device. Work closely with regulatory authorities to ensure compliance.
Clinical evidence
Ensure your clinical study data is readily-accessible to support your key milestones like regulatory approval, reimbursement, and marketing claims.
Label expansion
Accelerate your expansion with experienced experts who can quickly add new indications, broaden patient populations, and adapt to diverse usage environments. Our experts provide the necessary data and evidence for regulatory entities.
"The projects are very interesting as they deal a lot with niche products, and products that are seeking for a market. The people are fantastic, funny, open minded, tolerant, adorable, intelligent, competent, but above all they are motivated."
Position
First & Last Name
"The projects are very interesting as they deal a lot with niche products, and products that are seeking for a market. The people are fantastic, funny, open minded, tolerant, adorable, intelligent, competent, but above all they are motivated."
Position
First & Last Name
I consider myself quite lucky that when I started as Director of Quality at our innovative SaMD start-up, we already were working with Proxima and Ellie Reynolds. It was invaluable to me to have a knowledgeable, collaborative and responsive partner in Ellie to help me build our QMS and to provide hands-on training in our eQMS, Greenlight Guru. Another great benefit of partnering with Proxima was that when extra help or expertise was required, Ellie always was quick to connect me with other resources on the Proxima team.
Director Of Quality
Matt Garrity
"The wonderful people at Proxima have been dogged champions for our success. Aside from being deeply experienced in our particular field and keenly knowledgeable on developing trends they take our success as personally as we do. That, as much as anything, has been the difference."
COO & Co-Founder
Geoffrey Lucks
We have had the pleasure of working with the Proxima team for over a year on overall regulatory strategy and support for FDA interactions. The entire Proxima team are unbelievably knowledgeable in this space with excellent communication skills, highly strategic thinking, and amazing customer service. We at Prenosis highly recommend them as a one stop shop for anything regulatory or clinical trial related, all offered at a very attractive price point.
CEO and Co-Founder
Bobby Reddy Jr.
Developing medical technology for children has unique challenges. The Southwest National Pediatric Device Innovation Consortium (SWPDC) is a consortium supported by an FDA grant to assist innovators with their pediatric device development as well as address their regulatory challenges. Proxima has been a strong partner for us in helping guide innovators quickly through their regulatory and clinical journey.
Physician
Chester J. Koh, MD
Proxima was instrumental to our success in getting breakthrough device designation for our product! The team was very knowledgeable and responsive and set us up for success. They made the FDA process easy to go through and prepared us for future interactions with FDA.
Co-Founder
Jade Doucet-Martineau
“As a busy surgeon developing a Class III implantable device I needed help with regulatory strategy and execution. I wanted someone that was as passionate about the device as I was and that could hit the ground running. Because PROXIMA supports emerging companies through Med Tech Innovator they were a perfect fit. Isabella also helped us manage other vendor relationships and kept things moving forward. I been very happy working with PROXIMA”
Founder
Marc Bessler, M.D.
"Proxima staff understood the needs of our company and took a vested interest in supporting our clinical trial’s aggressive timeline while safeguarding our goals and objectives. Proxima has been a true partner for our early stage medical device startup!"
Sr. VP, Marketing & Clinical Development
Zaffer Syed
“Proxima has been such a wonderful help every step of the way. Everyone is truly great to work with.”
Junior Project Engineer
Karen Wells
We joined forces with Proxima's Quality Consultants to ready ourselves for upcoming audits of both our QMS and our parent company's QMS. Their approachable, expert team delivered essential support and insightful guidance, never shying away from directing us confidently towards the right path. We are proud to share our spotless ISO 13485 recertification audit, a testament to Proxima's steadfast commitment and fearless leadership!
Regulatory & QA Manager
Michael Selva

FREQUENTLY ASKED QUESTIONS

Does FDA require IRB review of off-label use of a legally marketed device?
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Glossary

Quality Management System
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Latest INsight

Proxima Clinical Research, Inc. Participates in FDA Sponsored Pediatric Medical Device Consortium
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Latest Video

Breakthrough Device Designation Timeline
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Looking to bring your next MedTech product to market?
Proxima's team of experts would love to work with you.
Speak with a Medtech expert