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.
The Preferred MedTech Partner
Find out why device, diagnostic and digital therapeutic companies
made Proxima one of the fastest growing CROs in the world
made Proxima one of the fastest growing CROs in the world
200
+
medtech
Clients
Clients
65
+
medtech
Submissions
Submissions
30
+
medtech Therapeutic & Industry Segments
Speed-to-market
MedTech moves 5x faster than drug development.
Partner with a CRO that can keep up.
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.
Areas of Expertise
Your agile CRO partner in
the following MedTech therapeutic areas
Watch An Innovator's Journey
Collaborate on your next regulatory or clinical milestone with us.
Ideas take time to grow. You build the vision. We'll handle the rest. Let's innovate together.
Tell us about your medtech productFREQUENTLY ASKED QUESTIONS
How do you prepare a 510(k) using the safety and performance based pathway?
Learn MoreGlossary
In Vitro Diagnostic (IVD)
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Isabella Schmitt: How to Create a Competitive Advantage in MedTech During Economic Instability
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Types of Medical Device Trials
Learn MoreLooking to bring your next MedTech product to market?
Proxima's team of experts would love to work with you.
Speak with a Medtech expert