If your medical device contains software—or if your device connects to a cloud platform that performs a clinical function—the international standard IEC 62304 almost certainly applies to you. It defines the requirements for software development and maintenance life cycles, establishing a common framework for planning, developing, testing, releasing, and maintaining software throughout its entire operational life.
46, 29.1, "Internationalization / localization considerations", Non-functional, "Address language/regulatory variations if applicable", "Localization plan, translated documents", "Localized versions validated", Not Applicable, Product Manager, , , Low,
Use Excel's DATA VALIDATION and IF formulas so that entering your software's safety class (A, B, or C) automatically flags which rows require mandatory compliance evidence. Iec 62304 Checklist Xls
Define who is responsible for verifying each checklist item.
13, 7.1, "Software maintenance process", Maintenance, "Plan and implement maintenance activities including problem resolution and change control", "Maintenance plan, change control procedure", "Issues tracked; changes controlled", Not Started, Maintenance Lead, , , Medium, If your medical device contains software—or if your
Here's an example of what the checklist might look like:
As she began to plan the project, Maria knew that she had to ensure that the software met the rigorous requirements of the medical device industry. Specifically, she had to comply with the IEC 62304 standard, which defined the lifecycle requirements for the development of medical device software. Define who is responsible for verifying each checklist item
To create your :
If you are developing medical device software, you have likely encountered IEC 62304 — the internationally recognised standard that defines the software life cycle processes for medical devices. Whether you are navigating your first regulatory submission or preparing for an audit, one question inevitably arises: how do you track compliance efficiently?
A summary of what the clause demands.
40, 23.1, "Record of decisions and rationale", Documentation, "Maintain decision logs for safety-critical design choices", "Decision log, meeting minutes", "Rationales traceable and auditable", Not Started, Project Manager, , , Medium,