Open AccessEfficient Quality Management in MedTech Start-Ups (Based on ISO 13485)
Author(s) -
Omar Kheir,
Sam Smedts,
Alexis Jacoby,
Stijn Verwulgen
Publication year - 2021
Publication title -
medical devices
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.482
H-Index - 30
ISSN - 1179-1470
DOI - 10.2147/mder.s320583
Subject(s) - certification , documentation , quality management system , quality (philosophy) , process management , guideline , key (lock) , engineering management , business , knowledge management , quality management , computer science , operations management , management system , engineering , medicine , management , computer security , philosophy , epistemology , pathology , economics , programming language
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.