Explained: Planning of product realization in ISO 13485 (Part 2)
In the ISO 13485:2016 standard is written what should be included in the planning of product realization in the chapter under this […]
Read moreTag: Medical Device
Explained: Planning of product realization in ISO 13485:2016 (part 1)
This chapter of the standards explains how one medical device company designs, develops, maintains and delivers medical device products. It covers the […]
Read moreWhat are the Outputs of Design and Development
The ISO 13485 standard requires the medical device company to define expected outputs in the end of any development stage. Design and […]
Read moreInfrastructure requirements in ISO 13485
Infrastructure in ISO 13485 is meant workspaces, process equipment, buildings, etc. Said in other words, to manufacture, design, or supply any medical […]
Read moreCan my medical device be produced by a non-ISO 13485 certified manufacturer?
To have or not to have? To certify or not? You want to produce a medical device. So, you decide to hire […]
Read more