Clinical Evidence · Methodology · Biostatistics
Clinical-evidence methodology for health startups and medical device manufacturers.
Clinical-validation studies, the CER literature and statistical core, PMCF statistics and real-world evidence. Direct to manufacturers; as a subcontractor to RA consultancies and CROs.
Who It Is For
Three buyers, one method core.
Medical Device Manufacturer
CER, PMCF and IVDR files
The sections a Notified Body sends back during the MDR and IVDR transition: systematic literature search, appraisal, equivalence, PMCF sample size, performance-study statistics. All device areas except the therapeutic area where I develop my own product.
Service scope →
RA Consultancy and CRO
White-label subcontracting
You keep the file and the client relationship; we deliver the literature and statistical core. Fixed scope, NDA, dual assessment. Named biostatistician on device studies, not principal investigator.
How we work →
SaMD and Medical-AI Startup
Standalone validation and SAP
Study design, locked SAP, reader study and external validation before the first submission; framed by TRIPOD-AI and MDCG 2020-1. Starts with a validation-readiness review.
Validation service →
Peer-Reviewed Publication
Clinical research published in an international peer-reviewed journal, 2026.
PROSPERO Registered
Four PROSPERO-registered systematic reviews; all accepted or in press in international peer-reviewed journals (2026).
Manufacturer Side
Intended use, software life cycle and validation strategy built for our own medical-AI device; we know the Notified Body language from the inside.
Technical Depth
End-to-end systems built, including DICOM pipelines, deep learning segmentation, and data curation. Work examples.
Service Segments
Clinical evidence for industry, method for academia.
Clinical Evidence
MDR · IVDR · SaMD
For medical device manufacturers, RA consultancies, CROs and SaMD startups: CER literature and statistical core, PMCF and IVDR performance statistics, standalone clinical-validation study, subcontract biostatistics. TITCK / EU-MDR / FDA.
Clinical evidence services →
Academic
Research & Method
Thesis and manuscript statistics, full systematic review process, meta-analysis, power analysis and ethics committee support, TUBITAK applications, and medical AI study design.
Academic services →
Enterprise
Data, AI and the AI Team
Company data pipeline setup, AI tool training, custom model development; a local-first AI employee crew for health startups.
Enterprise services →
Guides
Reading before you start.
Free, practical guides on MDR and IVDR clinical evidence, PMCF and systematic reviews.
Also · For Health and Medtech Startups
An AI employee crew for health startups.
For medtech, biotech, digital health, diagnostics, and medical device startups; AI employees dedicated to regulation, quality, research, and business-intelligence roles. They do the work and report back to you; nothing is sent, filed, or published without your approval. Local-first and bring-your-own-key: your sensitive data stays on your own machine. We build the crew as Serteser Danismanlik and power it with regulatory expertise.
References
From the academics we work with.
Academic title and scope of collaboration are shared instead of names.
It was a huge help in avoiding a manuscript mess in a field I did not know. Seeing the methodology and meta-analysis process done with such care matters a lot.
Assoc. Prof. Dr.
Systematic review and meta-analysis collaboration
We ran the entire technical process together, from the ethics committee application through data collection and analysis. Fast and meticulous work.
Asst. Prof. Dr.
Clinical research and AI study design collaboration
Congratulations, a very meaningful study. Thank you for your efforts.
Prof. Dr.
Joint systematic review study
Publications and Records
Peer-reviewed publication, open record.
Led by a biomedical engineer (BME MSc) with published methodology, a peer-reviewed publication, and PROSPERO-registered systematic reviews.
Peer-Reviewed Publication
AI-assisted clinical research published in an international peer-reviewed journal (2026).
PROSPERO Registered
Systematic reviews and meta-analyses registered on PROSPERO, conducted in line with PRISMA 2020 and Cochrane RoB 2 standards.
First Step
Let us talk first, then a proposal.
A free 15-minute intro call. We clarify the scope and draw up an impartial roadmap. Pricing is scope-based and set after a free scoping call.
or leave a quick message
or email directly: burak@serteser.com.tr