Medical Device Development, Preclinical Evaluation and Validation Expertise

Innoway R&D Kft. provides multidisciplinary expertise covering the full development cycle of medical devices, from early-stage concept design to preclinical evaluation and validation.

Our expertise includes the design and development of innovative medical devices, with a strong focus on functionality, safety, manufacturability, and clinical relevance. We support technology readiness advancement through structured preclinical workflows, including in vitro testing, ex vivo models, and in vivo preclinical studies where applicable.

In addition, we offer comprehensive validation support, encompassing performance verification, biocompatibility considerations, usability, and risk-based validation strategies aligned with international standards (e.g. ISO, MDR-oriented development pathways). Our approach bridges engineering, life sciences, and regulatory awareness to enable effective translation from laboratory to clinical and market-ready solutions.

This expertise is particularly suited for collaborative R&D projects, EU-funded programmes, and industry–academia partnerships aiming to accelerate medical device innovation and de-risk translational development.