10 / Software Requirements Specification Medical device software · IEC 62304

Kinetrace Connect — Class B software requirements

Requirement set for the companion mobile application of the Kinetrace R1, written to IEC 62304 with each requirement traced to its originating risk control and its verification method.

DisclaimerKinetrace R1 and Kinetrace Connect are fictional products created for this portfolio. Document numbers, revision history and clinical figures are illustrative. No proprietary or client material is reproduced. The regulatory structure and document conventions are real.

Document: KIN-SRS-0002
Revision: 07
Safety class: Class B (IEC 62304)
Traces to: KIN-RMF-0004
Status: Approved

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About this documentRequirement set for the companion mobile application, written to IEC 62304 with each requirement traced to its originating risk control and its verification method.

2.1 Safety classification rationale

Kinetrace Connect is classified Class B under IEC 62304 clause 4.3. Failure of the software cannot result in death or serious injury, because the device delivers no stimulation and applies no force to the patient. Failure can result in non-serious injury, because an incorrect exercise prescription displayed to the patient may cause strain to a recovering muscle. Class A was rejected on that basis.

3.2 Session integrity requirements

ID	Requirement	Risk control	Verification
`SRS-034`	The application shall not start an exercise session unless electrode contact impedance is below 20 kΩ on both channels.	`RC-11`	Test, bench simulator
`SRS-035`	The application shall display the prescribing clinician's name and the prescription date on the session start screen.	`RC-07`	Test + usability validation
`SRS-036`	Where a prescription is older than 90 days, the application shall block the session and display a message directing the patient to contact their clinician.	`RC-07`	Test, boundary values 89/90/91
`SRS-037`	The application shall end the session and record the reason where sensor data is not received for more than 5 consecutive seconds.	`RC-14`	Test, fault injection
`SRS-038`	The application shall retain unsynchronised session records locally for a minimum of 30 days and shall not delete a record before the server has acknowledged receipt.	`RC-19`	Test + code review
`SRS-039`	The application shall record the firmware version of the connected band against every session record.	`RC-22`	Inspection of stored record

Traceability noteRequirements SRS-035 and SRS-036 derive from the same risk control (RC-07, "patient performs a superseded exercise prescription") and are verified together in protocol KIN-VER-0012 §4.3.

5.1 SOUP inventory

Software of unknown provenance is itemised per IEC 62304 clause 8.1.2, with the functional and performance requirements each item must meet recorded against it.

Item	Version	Purpose	Anomaly review
SQLCipher	`4.5.6`	Encrypted local session store	CVE feed, monthly
Bluetooth stack (platform)	`OS-supplied`	Band connectivity	Vendor release notes per OS update
Charting library	`3.9.1`	Activation trace rendering	Issue tracker, quarterly

Standards applied

IEC 62304 ISO 14971 IEC 62366-1 EU MDR Annex I §17 (electronic programmable systems)

Authoring notes

Each requirement is written as a single testable statement using "shall", with one behaviour per line, so a verification protocol can address it without interpretation. The 90-day boundary in SRS-036 is stated as a number rather than "recently", because a tester needs to know whether day 90 passes or fails — which is why the verification column names the boundary values. The classification rationale states why the lower class was rejected; auditors ask for that reasoning far more often than for the classification itself.