Documents

Changes in technology call for changes in the ways we use that technology. This means that the instructions for use which are used as a tool to help users operate a medical device must also change and adapt. While using paper-based...

Quality and performance standards are revised every three to five years, or sometimes sooner, depending on the industry need. European regulations accept European specific versions of ISO standards when assessing conformance of the product and the organization’s quality management system. The...

If you are in the Life Sciences Industry you have heard of FDA Guidance Documents, and specifically, if you are in a business where you have had to have some interaction with the FDA, you have likely made use of...