Medical Devices: Evidence and Research (Oct 2021)
Efficient Quality Management in MedTech Start-Ups (Based on ISO 13485)
Abstract
Omar Kheir, Sam Smedts, Alexis Jacoby, Stijn Verwulgen Department of Product Development, Faculty of Design Sciences, University of Antwerp, Antwerp, BelgiumCorrespondence: Omar Kheir Tel +31657019567Email [email protected]: Start-ups that are involved in the development of medical devices play a key role in innovation, yet among the several limitations they encounter, they suffer a lack of knowledge in quality management. This lack may create a challenge that could hinder or limit their success. This paper seeks to present an overview and act as a guideline for the required documentation to establish a quality management system for start-ups in medical devices development, based on a case-studied start-up, in accordance with ISO 13485. Using this case study along with the actual ISO 13485 standard document, can support medical devices start-ups in their ISO compliance and certification journey.Keywords: ISO, innovation, medical, start-up, quality, compliance, documentation
