ISO 13485 – a norm for the design and manufacture of medical devices

ISO 13485 is an International Organization for Standardization (ISO) standard, published for the first time in 1996, representing the requirements for a comprehensive “quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements“.

Compliance with ISO 13485 can be seen as the first step to compliance with European regulatory requirements of Medical Devices and In-vitro Diagnostic Medical Device, according to European Union Directives 93/42/EEC, 90/385/EEC and 98/79/EEC. This compliance must be assessed before the sale is permitted.

What are the benefits of being certified to ISO 13485?

First, as previously stated, the compliance with the norm must be assessed before the sale is permitted. Rather than that, there’s a list of reasons why ISO 13485 might be a good idea for your organization:
– To increase access to more markets which share this certification
– To demonstrate that your products are safe and more effective,
– To improve your credibility, meeting the market highest standards and customer expectations.
– To improve customer satisfaction, by identifying and meeting their needs:
– To review and improve your processes, finding areas for improvement and increasing efficiency
– To create a culture of continuous improvement

If you are managing  your ISO 13485 Quality Management System and want to see how we can help you, sign up now and start your free 14 days trial.