Digitalization, AI and Regulations in Medical Technology with the Industry Software medtec365
Digitalization, AI and strict regulatory requirements are shaping today’s medical technology sector. This presentation uses the industry software medtec365 to demonstrate how companies can leverage AI and digital platforms efficiently while remaining fully compliant with MDR.
The medtech industry faces a dynamic tension between rapid digital transformation, the growing use of artificial intelligence (AI) and a highly regulated legal environment. Software‑based medical devices, AI‑driven assistance systems and data‑centric business models present companies with new technological, organizational and regulatory challenges—while also unlocking significant potential for efficiency and quality improvements.
The presentation explores this landscape using the ERP software medtec365. It illustrates how digital platforms and AI methods can be integrated across end‑to‑end business processes without losing sight of MDR or ISO 13485 requirements. Alongside technological aspects, the presentation also addresses key regulatory questions—for example: How can validation be automated in the cloud? We will present solution concepts for this.
This presentation is aimed at decision‑makers, developers and quality managers who want to anchor digitalization and AI strategically and compliantly within the medical technology sector.
Speakers (1)
Jens Fröhlich
Principal Consultant Medtec, KUMAVISION AG
