ISO 13485 Quality Management System – Certification Consultants

How do you manage your Quality Management System? If you're like the majority of the medical device industry, chances are you have a QMS that's a combination of paper- based processes and general purpose tools, approximately held together by a group of people within your company– generally document control.
It’s important because it's long overdue with the former interpretation being released 13 years before in 2003.
The 2016 standard is veritably much a bridge. What I mean is that this bridge explicitly describes and defines current QMS prospects for medical device companies. Prior to these advances being formally defined and documented in the standard, numerous of the best practices being advised and adopted were veritably ad hoc in na