SaMD - Software as a Medical Device - Software change control form

racglobal

Involved In Discussions
#1
Hello everyone,

For a company that makes SaMD, (software as a medical device), does anyone have a design change control form template? I know in the world of hardware devices, there are engineering change controls and the associated forms where you assess the impact. Does the world of software have difference requirements on the change control form? Can somebody provide some insight and a template they would like to point me to ?


Thanks.
 
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yodon

Staff member
Super Moderator
#2
It's still a medical device so I would suggest you always:
  • [from 13485] assess (and document) the significance of the change to function, performance, usability, safety and applicable regulatory requirements
  • [from 13485 and effectively 820] document what you did regarding review, verification and/or validation, and approval (to make the change)
  • [from 13485] assess (and document) the effect of the changes on constituent parts and product in process or already delivered, inputs or outputs of risk management and product realization processes.
  • [from 62304] assess (and document) the effect on the organization, released MEDICAL DEVICE SOFTWARE, released for intended use, and SYSTEMS with which it interfaces
  • [from 62304] assess (and document) a statement of criticality (for example, the effect on performance, SAFETY, or SECURITY) as well as other information that may aid in the resolution of the problem (for example, devices affected, supported accessories affected)
  • [from 62304]
    1. investigate the problem and if possible identify the causes;
    2. EVALUATE the problem’s relevance to SAFETY using the software RISK MANAGEMENT PROCESS;
    3. document the outcome of the investigation and evaluation; and
    4. create a CHANGE REQUEST(S) for actions needed to correct the problem, or document the rationale for
      taking no action.
  • [from 62304] advise relevant parties of the existence of the problem, as appropriate
You should also consider the impact on usability [62366].

Your form can facilitate driving/capturing all this.
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#3
Also evaluate the user experience change from the software iteration. A 510K alteration review is advice from FDA that should be reviewed with all SW changes. Regression testing deliberation should also be documented.
 

Lokus200

Starting to get Involved
#4
Same change process applies to all medical devices, you will have to follow the same process.
I assume as a software developer you are using tools such as JIRA to document defects, you can adjust your tools to include the change process instead of creating additional paperwork. Just make sure you add regulatory evaluation of every change and document why new 510k is not required.
 
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