Your severity ranking should relate to what you consider relevant harms. Financial harms could be one. Some companies even use multiple scores in...
Change control requires systems thinking: you must identify all elements (specifications, work instructions, software, validation requirements, et...
Please read the attached guidance document published by Health Canada GD210: ISO 13485:2003 Quality Management System Audits Performed by Health...
It is a bit of both. Design is about making things suitable for the intended user, considering the skills of the user group. E.g. if you design a...
Separate names with a comma.