Is your organization keeping up with the increasing regulatory requirements for medical devices?
The medical device industry has recently been, and will most likely continue to be, subjected to strengthened regulatory requirements. The increased focus on the medical device industry has resulted in the replacement of the Medical Device Directive (MDD) with the Medical Device Regulation (MDR), taking effect May 26, 2020, and the update to the ISO 13485 standard from 2016.
Among the newly introduced regulatory requirements are requirements related to Validation of IT systems, which support an organization’s quality management system. Included in this scope are both newly introduced systems as well as systems currently in use.
HERAX has experience from projects in this area and can support your organization with:
- Development and implementation of a risk-based methodology and framework for retrospective validation
- Risk-based assessment and planning
- Management and execution of retrospective validation activities