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.

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 (PMCF)
  • Implement changes to the product, its 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 Generation

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 Scientits 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

Trusted Real World Evidence
for Medical Device compliance

Driven by our advanced analytics & AI capabilities and our proven expertise and experience in Real-World Evidence (RWE) generation, we deliver retrospective Post-Market Clinical Follow-up studies (PMCF studies) for Class IIa, Class IIb & Class III Medical Devices based on Real-World Data.

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 requirements and help our clients deliver relevant data to their Notified Bodies.

CONTEXT

Harness the potential of Real-World Data for your PMCF studies

Bringing our expertise and capabilities to help manufacturers face the MDR challenges and provide Notified Bodies with all the needed clinical evidence to confirm safety and performance of their medical devices.

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
  • Renew the CE mark to keep the device on the market
  • Implement changes
    to the product, its intended use or indications for use
  • Address unanswered questions
    of long-term safety and performance
  • Report high risk related to
    the product or a patient’s population
  • Collect more evidence and more data on devices
  • Handle specific request from the Notified Body

To learn more, speak with us today

METHODOLOGY

Our innovative approach to PMCF studies to generate RWE and support clinical evaluation

  • Innovative approach combining best practices of RCTs, observational studies and specific features of Real-World Data
  • Protocol production driving the overall study and fitting the regulatory purposes
  • Collection of clinically rich Real-World Data (from Electronic Medical Records, prescriptions, labs, diagnoses, interventions, providers notes, claims data…)
  • Preferred access to the Medical Expertise of the hospital’s physicians

Novel approaches to structured and unstructured data collection for a comprehensive clinical profile of the patient

Effective combination of heterogeneous data of multi-center PMCF studies to reinforce analyses and strengthen clinical outcomes

  • Latest technology for data processing and analyses
  • Automized processes and tools to accelerate study execution 
  • Robust Quality Control to secure reliability of analyses outputs

Legal procedures and security certifications to ensure data privacy protection and high-quality standards

  • Standard and complete study reports production providing adequate scientific insights to be leveraged for support regulatory decision making
  • Clinical evidence delivery to be directly integrated in the clinical evaluation report (CER)

ADVANTAGES

Quinten Medical Device’s advantages

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

Leverage new technologies & methodology
and reduce time

Regulatory and Quality
framework adapted
MR004 & ISO 27001

Want to know more about our solutions?

OUR TEAM

Meet the leadership team

Philippe Arany
Philippe ARANY
President
Lucas Davy
Lucas DAVY
CEO
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Frédéric Couriol
Frédéric COURIOL
Managing Director
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Jihane Tamine
Jihane TAMINE
COO
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Jihane Tamine
Iris VERBOVEN
Head of Business Development
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