SERVICE 02

IVDR Literature Searches & Performance Evaluation Support

The successful approval and market surveillance of in-vitro diagnostics (IVDs) under the European Regulation (EU 2017/746) requires comprehensive and methodologically rigorous documentation of clinical and scientific evidence. Zelsya supports manufacturers of high-end diagnostics as a specialized partner. We relieve the burden on your regulatory affairs and clinical affairs teams precisely where standard statistical analyses fall short and in-depth molecular biology expertise is essential.

We conduct methodologically sound evidence syntheses, analyze the worldwide peer-reviewed literature and prepare the data in such a way that it meets the extremely high requirements of notified bodies and auditors. We develop Literature Search Plans and Literature Search Reports - neutral, transparent and regulatory compliant.

In-depth molecular biological expertise in the regulatory process

Unique diagnostic procedures require equally unique validation. We don't just review published studies according to formal criteria, but delve into the underlying science:

BIOLOGICAL PLAUSIBILITY CHECK

Thanks to our roots in genomics and molecular biology, we assess the functional relevance of genes, complex gene panels, and biomarkers. We translate biological mechanisms into the arguments required by law to demonstrate scientific validity.

METHODOLOGICAL CRITICAL APPRAISAL

We critically analyze the study design of published articles for sensitivity, specificity, sample sizes and potential biases in order to create an irrefutable data basis for your performance evaluation.

SPECIALIZATION IN NEXT-GENERATION DIAGNOSTICS

We understand the subtle nuances of modern high-performance methods – from Next-Generation Sequencing (NGS) and Multiplex PCR to Liquid Biopsy and complex screening procedures.

Our services at a glance

Performance Evaluation Reports (PER): Systematic collection and synthesis of the global research landscape for the clinical performance evaluation report.

Post-Market Performance Follow-up (PMPF-R): Conception and implementation of continuous, methodically documented literature screening during the post-market-surveillance to maintain your marketing authorization.

PSUR delivery (Class C & D): Creation of precise, annual literature updates that seamlessly integrate into your Periodic Safety Update Report.

Instructions for use (IFU): We write instructions for use and testing principles including information on genes and genomic sequence locations.

Your advantage: Technical Expertise & Efficiency

IN-DEPTH GENOMICS EXPERTISE

We thoroughly desribe the genes and sequences that underlie your testing principles and reference genomic loci in up-to-date databases. You work with experts on equal footing who immediately understand your technology.

LEGALLY COMPLIANT IVDR

Our systematic searches and documentation are strictly based on the current MDCG guidelines and the expectations of the Notified Bodies.

RESOURDE RELIEF

We take over the time-intensive, methodical screening and critical evaluation of the literature, so that your internal teams can concentrate fully on strategic product development and risk management.