Introduction to ISO 13485 Quality Management System for Medical Devices

Join this webinar to learn more about the

• Regulatory environment for MedTech developers
• Purpose and benefits of ISO 13485
• Subjects and contents of this piece of QMS regulations

Abstract

For MedTech developers, ISO 13485 is a crucial standard that contains key requirements on Quality Management Systems for medical devices. Understanding this piece of regulation is vital to developing high-quality and safe medical technology products.

In this webinar (Part 1 of our 2-episode series on ISO 13485), QMS experts from Resyca and Intland Software provide an introduction to ISO 13485. Join the session to understand who the standard applies to, what it contains, and how it affects developers of medical technology. In Part 2, we’ll focus on actionable best practices for building an ISO 13485-compliant Quality Management System.

About our hosts

Laszlo Katona
Senior Solution Engineer at Intland Software
Laszlo is an ISO 13485 internal auditor and a certified Quality Management Specialist.

Danish Mairaj
Development Engineer at Resyca
Danish has over 10 years of medical device design and development experience with a strong background in MedTech regulatory compliance and quality management.