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Evidilya, People & Research First®
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Domain · MedTech & Medical Devices

Device evidence, built in from design.

Pre-market clinical investigations and post-market clinical follow-up (PMCF) for medical devices, including botanical and borderline devices, around MDR/IVDR and continuous real-world capture.

Submit an RFPDiscover ECS®
People & Research First®
The problem

MDR turned evidence into a continuous obligation.

Under MDR and IVDR, a device's evidence burden no longer ends at CE marking, PMCF and real-world performance are ongoing. Manufacturers need a partner who treats device research as a core discipline.

The solution

Device research, as a discipline.

  • Clinical investigations
    Pre- and post-market studies scoped to MDR/IVDR and device class.
  • PMCF programmes
    Continuous follow-up with structured real-world performance capture on ECS®.
  • Botanical & borderline
    Expertise where device, FSMP and consumer-health boundaries meet.
  • Pharmacy & territorial channels
    For self-care and OTC devices, activate studies through pharmacies and territorial HCPs, beyond hospital centres.
  • Connected capture
    Wearables, sensors and EHR feeds ingested for source-verified evidence.
  • Materiovigilance & PMS
    Materiovigilance and post-market surveillance (PMS) per MDR/IVDR, incident capture, trend analysis and periodic safety update reporting on ECS®.
Why evidence is needed here

The scientific rationale.

  • Safety and effectiveness profiles evolve as exposure increases post-market.
  • Continuous product modifications limit the feasibility of classical phased development.
  • Rare adverse events require large, real-world populations for detection.
Study designs we deliver

Study designs that hold up scientifically, tailored to device-specific constraints.

01
Interventional evidence

Interventional evidence

  • EU MDR/IVDR support, technical documentation and CE-marking strategy
  • Pragmatic and adaptive interventional designs
  • Performance endpoints aligned with intended purpose
  • Device-related safety and usability outcomes
  • Early clinical experience and feasibility investigations
02
Observational & epidemiological

Observational & epidemiological

  • Prospective and retrospective cohort studies
  • Registry-based investigations with hypothesis-driven design
  • Case-control and nested designs for rare safety signals
  • Longitudinal outcome and durability assessment
  • PMS/PMCF, CERs and benefit-risk re-assessment
Study selection is driven by device class, clinical risk and evidence gaps, protocol by protocol.
Why it works

Why manufacturers choose Evidilya.

  • Device research is a core domain, with the regulatory vocabulary manufacturers expect.
  • ECS® makes continuous real-world capture native, the exact shape PMCF requires.
  • Phygital recruitment reaches real users in real settings, where devices are actually proven.
  • European, ISO 9001 certified, GDPR and EHDS-ready.
Related
Clinicians in the loop

Devices earn evidence where they're used.

MedTech studies live at the bedside and in the home, investigators, engineers and participants aligned on one platform, with connected capture that respects clinical workflow.
Clinicians reviewing a connected medical device with a patient
Regulatory frameworks

We design evidence against the framework that regulates your device.

The design of a study, endpoints, population, comparator, statistical plan, is a function of which authority will read the evidence. We start there.

  • MDR 2017/745 · Regulation (EU)
    Medical devices, Class I–III

    Pre-market clinical investigation and post-market evidence for devices placed on the EU market.

    EvidenceClinical Evaluation Report, clinical investigation per ISO 14155, benefit-risk documented per class.
  • MDR · Annex XIV Part B (PMCF)
    Post-market clinical follow-up

    Continuous confirmation of safety and performance once the device is in routine use.

    EvidencePMCF studies, registries and real-world performance data, feeding the PSUR and the CER update cycle.
  • IVDR 2017/746 · Regulation (EU)
    In-vitro diagnostics

    Performance evaluation across scientific validity, analytical and clinical performance.

    EvidencePerformance studies, performance evaluation report, post-market performance follow-up.
  • FDA · 21 CFR 812 / 510(k) · PMA
    Devices, US pathway

    Investigational device exemption, substantial equivalence or premarket approval, per risk class.

    EvidenceClinical data package, human factors, post-approval studies where the pathway requires them.
Why generate evidence · beyond the claim

Evidence builds clinical acceptance, and the right to be cited, adopted and included in guidelines.

In medtech, evidence is not only a CE / FDA prerequisite. It is what earns clinician trust, drives inclusion in clinical pathways and guidelines, and gives sales and medical education something HCPs will actually read, cite and recommend.

Clinical equity

A defensible body of evidence that positions the device inside a clinical pathway.

Scientific authority

Peer-reviewed data, congress presence and KOL endorsement that support guideline inclusion and formulary decisions.

HCP engagement licence

Evidence that gives medical education, MSLs and reps something clinicians will read, cite and integrate into practice.

Delivered through AIRA, advisory boards & KOL and publication & scientific communication.

Plan your MDR/IVDR evidence path.

From CE-marking strategy to continuous PMCF, we design the device evidence programme your class and risk profile requires.

Submit an RFPDiscover ECS®