Submodule: SPE327c7 — Scientist Training Programme | Curriculum Library

#	Learning outcome	Competency	Action
# 1	Learning outcome 1,2,3	Competency Apply medical device risk management knowledge and engineering principles to identify prevailing medical device-related risks within the institution	Action View
# 2	Learning outcome 1	Competency Develop medical device risk management strategies for the institution	Action View
# 3	Learning outcome 1	Competency Develop a policy for the organisation to help manage risk	Action View
# 4	Learning outcome 2	Competency Execute a number of complex medical device- or service-related risk assessments	Action View
# 5	Learning outcome 3	Competency Advise on practical risk management actions in medical device risk management and governance	Action View
# 6	Learning outcome 3	Competency Authorise modifications to medical devices having analysed the associated risks	Action View

You must complete:

Draft a risk management strategy for the department	DOPS
Identify means to ensure compliance with CQC requirements for the safety and availability of equipment	DOPS
Undertake a project involving analysis of risk and proposal of solutions to mitigate involving a clinical department	DOPS
Modify a medical device and follow necessary procedure	DOPS
Authorise modifications to medical devices having analysed the associated risks	DOPS
Identify key patient risks that exist in the organisation in relation to the acquisition and use of medical devices	DOPS
Draft a strategy to minimise the risks associated with modifying medical devices and present to colleagues	OCE
Advise a clinical colleague on on a practical risk management actions in Medical Device Risk Management & Governance	OCE
Carry out an "Outcome Guardian Audit" in a clinical area	OCE

Expertise in Medical Device Risk Management