Software as a Medical Device Regulatory Compliance
Innovators in digital healthcare often need help understanding the regulatory compliance requirements needed to gain approvals to use their software products in the UK, EU & USA.
To achieve compliance, you will need people, processes and technologies. Below is a set of processes and technology resources that can help you. They are diagrams and a set of AI Agents you can engage to understand the issues you will need to address, for example, to obtain a CE mark.
As and when you start to gather the data required for compliance, AutoDeclare will enable you to monitor your readiness to be formally audited by the designated/notified bodies.
To achieve compliance, you will need people, processes and technologies. Below is a set of processes and technology resources that can help you. They are diagrams and a set of AI Agents you can engage to understand the issues you will need to address, for example, to obtain a CE mark.
As and when you start to gather the data required for compliance, AutoDeclare will enable you to monitor your readiness to be formally audited by the designated/notified bodies.
Notes on Risk Classifications
- Low Risk (Class A / Class I):
- IEC 62304 Class A, UK Class I, FDA Class I: All these classifications share a similar definition of low risk, where the potential for injury or risk to patient health is minimal. They generally involve devices or software with non-critical functions.
- Medium Risk (Class B / Class IIa / Class II):
- IEC 62304 Class B, UK Class IIa, FDA Class II: These classifications align on the concept of medium risk, where there is potential for non-serious injury or moderate risk. These are often devices or software that require some level of regulatory control to ensure safety but are not considered high risk.
- High Risk (Class C / Class IIb / Class III):
- IEC 62304 Class C, UK Class IIb, FDA Class III: These classifications are associated with high risk to patient safety, where errors or failures could result in serious injury or death. The UK further distinguishes between Class IIb (high risk, sustained use) and Class III (highest risk, critical devices), while the FDA Class III generally covers the highest risk devices.
- Highest Risk (Class III):
- UK Class III: Represents devices that have the highest risk according to UK regulations, requiring the most stringent regulatory scrutiny, similar to FDA Class III devices
SAM-D
Use SAM D below to ask questions about software as a medical device compliance based on your review of the compliance and documentation requirements shown in the links above. It specializes in software with AI components.
Alternatively, if you wish to understand the application of standards and risk management in AI development, engage the Stan and PRIDAR AI Agents. Or engage the full range of AI Agents that support Digital Healthcare at Public Interest AI.
We would be pleased to hear if you have any questions not covered by these assets. Reach out via our Contact Us page
Alternatively, if you wish to understand the application of standards and risk management in AI development, engage the Stan and PRIDAR AI Agents. Or engage the full range of AI Agents that support Digital Healthcare at Public Interest AI.
We would be pleased to hear if you have any questions not covered by these assets. Reach out via our Contact Us page
Feedback on this this tool can be provided here