ISO 13485:2016

What must I do to kickstart my design process?

What must I do to kickstart my design process?

With Design and Development (D&D) being a core process of your business, having a clear D&D work structure is important. The structure your Quality Management System provides helps with maintaining systematic business practices for maximum efficiency. Here are 5 items to be set in place at the start of your D&D work structure.

What is the difference between R&D and D&D?

What is the difference between R&D and D&D?

Many companies recognise that it is important and beneficial to set up a Quality Management System (QMS) while still early in product development stage, but still find it a challenge to decide when to put in place a QMS. Most often, a good gauge would be when business operations have moved from Research & Development (R&D) stage to Design & Development (D&D). But what defines that transition?

3 Lessons learnt by a medical device software company adopting ISO 13485:2016

3 Lessons learnt by a medical device software company adopting ISO 13485:2016

It is clear that having a Quality Management System that meets ISO 13485 standards brings many benefits. However, it is not as easy as it sounds. We spoke with Mr. Encey Yao, the Management Representative at Qritive Pte. Ltd., a medical device software company that recently completed its certification for ISO 13485:2016. He shared with us some insights to challenges faced, that would be shared by similar software companies.