A Quick Overview of ISO 13485 Requirements for Medical Device Companies

It is an undeniable fact that safety and quality are the top-most priority for medical device companies. However, the best-practices to maintain these priorities are defined under ISO 13485. You cannot brush aside the need for implementing the right enterprise quality management software to create and maintain the culture of quality and continuous improvements. The software may help you meet compliance with next-generation features and functionalities like electronic signature and documentation, outgrowing the limitations of traditional practices.

The quality of medical devices directly impacts the safety of the patients. It is the reason that regulatory bodies require medical device manufacturers and suppliers to implement an internal quality system where all the activities are performed, documented, audited, and verified. Without a validated quality system, they may lose growth and improvement opportunities. They may also experience unnecessary delays to enter the major markets and earn a better share of profitability.

Before selecting the right quality management software, it is imperative for you to know and understand the critical requirements of ISO 13485. You are likely to get a checklist of considerations and features to look for while selecting your organization’s right quality management system.