Clinical Safety Management/Officer Support – Hazard Log and Safety Case support

We offer our Clinical Safety Management / Support service for clients who have decided to employ their own Clinical Safety Officer (CSO) but would like the support of our team for advice and guidance. Our team offers medically qualified technology experts experienced in product management, agile development, and risk management.
Price for 10 Hour pack – hours can be booked directly into our teams diaries when you need them and can include:

• Discussions with relevant personnel (development, product, customer success, support) to understand your current business processes and product lifecycle 
• Creation of documented clinical risk management process that aligns with this
• Establish your multidisciplinary team clinical risk management team and walk through the risk management process with them 

• Work with you to create the initial set of DCB0129 mandatory documents: 

• Clinical Safety Case Report 
• Hazard Log 
• Clinical Risk Management Plan 
• Clinical Incident Log