Introduction:
It is essential that personnel involved in the Medical Device industry have a good foundation in Regulations and Guidelines and the Quality Management System (QMS) and can apply the knowledge to their daily activity.
Subsequent Notified Body (NB) and /or Regulatory audits/inspections will assess the company's overall conformance and compliance with regulations and guidelines and the "status" of the QMS.
This training course will cover the following topics to help you prepare for your next Notified Body or Regulatory Authority audit.