We guide manufacturers of health IT systems through the DCB0129 clinical risk management standard. Our structured approach ensures your product is safe for clinical use and fully compliant.
11 Step Compliance Process for DCB0129
Explore our three-phase approach to see how we drive growth and efficiency at every step.
Step
01
Initial Assessment
We begin by understanding your health IT system, its intended use, and the clinical context to determine the scope of the DCB0129 standard.
Step
02
Clinical Risk Management Plan
A detailed plan is drafted, outlining the risk management activities, responsibilities, and criteria for risk acceptability.
Step
03
Hazard Identification & Risk Analysis
We conduct systematic workshops to identify potential hazards and analyze the associated clinical risks to patients.
Step
04
Safety Case & Compliance Report
Finally, we compile the Clinical Safety Case Report, demonstrating the safety of the system and full compliance with the DCB0129 standard.
By clicking "Accept", you agree to the storing of cookies on your device to enhance site navigation, analyze site usage, and assist in our marketing efforts. View our Privacy Policy for more information.
.jpg)
