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

BENEFITS

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 prospective study)
• Transparent and flat fees from-end-to-end

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

Want to take advantage of this benefit?

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 the our solution?

KEY FIGURES

12+

years in Healthcare and Medical Devices

5

years in Real World Evidence Generation

360°

in-house dedicated expertise and academical background

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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Do you need further information regarding our solutions, our expertise or our company?
Please contact us by filling out our contact form, we will answer you within 48 hours