Ilkka Juuso

This book simplifies the process regarding the application of usability to medical devices for new developers by providing a thought-out walkthrough of what is involved and how the expectations from the essential standards affect their work and why. Meer

Developing an ISO 13485-Certified Quality Management System: An Implementation Guide for the Medical-Device Industry details the lessons learned from a real-world project focusing on building an ISO 13485:2016 Quality Management System (QMS) from scratch and then having it officially certified. Meer