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Trusted Real World Evidence
for Medical Device compliance

We provide you with clinical data and generate clinical evidence to support your regulatory processes and MDR compliance

Our innovative model enhances the clinical evaluation of medical devices, reducing costs & delays and minimizing risk in order to strengthen the compliance with the Medical Device Regulation (MDR) requirements and deliver relevant data to Notified Bodies.

OUR OFFER

Retrospective clinical studies for high-risk medical devices based on Real-World Data (RWD)

Our services are fully in line with the context of the new regulations.

We use our advanced analytics and AI capabilities, as well as our proven expertise in Real-World Evidence (RWE) generation and conduct retrospective clinical studies for high-risk medical devices based on RWD.

Find out more about our services

Entry into force of MDR: Stricter regulation in Europe requiring more clinical evidence
Rise of Real-World Data: New sources of rich and exploitable data 
Emergence of new Technologies: New data processing and analytics technologies.

Want to know more about Real-World Data and Real-World Evidence?
Please visit our page describing the data we use in our studies


YOUR NEEDS

Harness the potential of Real-World Data to confirm safety and performance

Our top priority is to help you address your needs.
Together, we explore your regulatory challenges in order to meet them with a tailored, innovative & effective approach.
By bringing our expertise and capabilities, we can help you to:

Our top priority is to help you address your needs.


Together, we explore your regulatory challenges in order to meet them with a tailored, innovative & effective approach.


By bringing our expertise and capabilities, we can help you to:

  • Transfer existing medical device certificates into MDR
  • Collect clinical evidence for the Post-Market Clinical Follow-up
  • Implement changes to product, intended use or indications for use
  • Address unanswered questions of long-term safety and performance
  • Renew the CE mark to keep your device on the market
  • Collect more evidence and more data on your devices
  • Handle specific requests from your Notified Body
  • Establish an ongoing process for collecting clinical evidence over time for your device

Let’s explore your needs together

BENEFITS OF WORKING WITH US

Accelerating regulatory success with RWE

Less than one year from contracting to results delivery
• Secured and defined trial design

-30% cost in average (compared to clinical investigation)
• Transparent and flat fees from-end-to-end

• High Quality and MDR compliant evidence
• Real-World Evidence (RWE) supported by regulatory authorities

Want to take advantage of this benefit?


OUR CAPABILITIES

Access to
Real-World Data & medical expertise
via a hospital network

Innovative technologies and methodology

Regulatory and Quality
framework
MR004 & ISO 27001

Want to know more about our solutions?

KEY FIGURES

13+

years in Healthcare and Medical Devices

5

years in Real World Evidence Generatio

360°

in-house dedicated expertise and academical background

OUR TEAM

Meet Quinten MD team

We are a dynamic and experienced consultants team of Clinical Project Managers, Biostatisticians, Data Analysts, Data Scientists and Clinical Research Assistants who understand the challenges of the medical device industry and want to put their expertise at the service of the manufacturers.

Biostatistician Quinten MD
Open space Quinten MD
Quinten Choose My company Labels
Meeting room Quinten MD

Need more information regarding our solutions, our expertise or our company?
Fill out our contact form, we will answer you within 48 hours