Initiate controlled device modifications through systematic evaluation and approval processes.
Product Name(s) | Version(s) |
---|---|
CardioTracker Mobile App | v3.2.0 and later |
CardioTracker Web Dashboard | v2.1.0 and later |
Software Item | Affected by Change (Yes/No) | Comments |
---|---|---|
Data Acquisition Module | Yes | Must capture additional R-R interval data |
Signal Processing Engine | Yes | New HRV calculation algorithms required |
User Interface Components | Yes | New screens and data visualization elements |
Data Storage Layer | Yes | Additional database fields for HRV metrics |
Export/Reporting Module | Yes | Include HRV data in generated reports |
Authentication System | No | No changes to user login or security |
Cloud Sync Service | Yes | Sync HRV data across devices |
Document / Process | Update Anticipated | Comments |
---|---|---|
Intended Use | Yes | Expand to include HRV monitoring capabilities |
Device Classification | No | Remains Class II medical device software |
User Needs list | Yes | Add user needs related to HRV analysis |
Risk Management File | Yes | Assess risks of HRV algorithm accuracy |
System Requirements | Yes | New functional requirements for HRV features |
Subsystem Requirements | Yes | Algorithm performance and accuracy specs |
Product Design / Architecture | Yes | Software architecture updates for new modules |
Verification or Validation Testing | Yes | New test protocols for HRV functionality |
Usability Testing | Yes | Test new user interface elements |
Clinical Evaluation | Yes | Evaluate clinical utility of HRV features |
Labeling or Informational Materials | Yes | Update user manual and marketing materials |
What is the role of the change request in the release process?
How can we streamline the version comparison process?
What is the process for preparing a new software release?
How should changes be documented when transitioning to new templates?
What should be considered when evaluating the impact of a change request?
Who should be involved in reviewing change requests?