When your Design History File (DHF) results in observations during regulatory audits or makes making design changes a scary thought, thoughtful, targeted remediation might be the answer to your problems.
Our approach to remediation -
Utilizes audits to determine where gaps exists
Prioritizes those gaps based on regulatory risk and product risks
Develops an implementation plan that defines and prioritizes how each gap will be addressed to help you ensure audit success and reduce risks posed by design changes
Provides resources to implement the plan
Provides training to ensure that the DHF is continuously maintained in good audit shape