Posts in Quality Management
Product Design & Development: Regulatory and Standards Overview

Medical device regulations require information to be recorded as you develop; this includes how the design was created, why design decisions were made, and what risks were considered in the process. Here is a basic outline to get you started.

Read More
4 Key Changes in the New European MDR

Last year, substantial changes to Medical Device Regulations (MDR) were approved by the European Council to take full effect in mid 2020. If you are planning to market a medical device there, it’s important to understand the new changes.

Read More
MDO Article: Why you need to care about marketing requirements to develop a medical device

Marketing requirements are actually a critical part of the medical device creation process. They establish a solid foundation for product development.

Read More