P-09 : Change Control Procedure

P-09 : Change Control Procedure


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Change control procedure (SOP) is nowadays essential for any Quality Management System within a regulated environment and both FDA and EU MDR 2017/745 requests particular attention to the management of significant changes in their medical device related regulations.

Here at QualityMedDev we show an example of change management procedure (SOP), fully compliant with ISO 13485 : 2016 and FDA regulations. In fact, the procedure define the framework for the evaluation of the significance of the changes according FDA guidelines or other guidelines applicable with EU MDR.

The process of change management is by far one of the pillar of any quality system. At the base of the process, there is always risk management and the necessity to evaluate the impact of the changes from risk point of view.

The contents of the change control procedure (SOP) is the following

  • Scope, where the goal of the procedure is defined
  • Responsibilities, which defines who is responsible for this process
  • Change control request, which is the act that triggers the opening of a change
  • The description of the change control process
  • The management of substantial changes, either as per FDA Requirements and per European Medical Device Regulation 2017/745

Do not hesitate to download the Change Control Procedure (SOP) fully compliant with ISO 13485 and FDA regulation 21 CFR 820!

For any questions or inquiries, please contact us : infot]qualitymeddev.com