The ISO 13485 standard requires the medical device company to

This part of the standard explains how employees whose actions

To have or not to have? To certify or not?

Small businesses collect numerous kinds of information - financial, employees,

Sustaining a paper-based quality management system is pretty hard and

ISO 13485:2016 requires companies to use risk-based thinking to manage

In a fast-paced world, the risks companies are exposed to

The new version of the ISO 13485:2016 standard expects companies

Traceability is at the heart of the product development process

A quality manual is a document that outlines the company’s