Software Development Plan (IEC 62304) – CardioMonitor Pro ECG-12¶

Document: Software Development Plan (SDP)
Product: CardioMonitor Pro ECG-12
Version: 1.1.0
Gültig ab: 17. November 2025- Erstellungsdatum: 17. November 2025- Letzte Überarbeitung: 17. November 2025- Creation Date: 16 November 2025
Letzte Überarbeitung: 19. November 2025- Last Revision: 16 November 2025
Nächste Überprüfung: 19. November 2026- Next Review: 16 November 2026
Approved By: [Quality Manager]
Responsible: [Software Project Manager]

1 Purpose¶

This plan describes the software lifecycle processes according to IEC 62304 for the device software of the CardioMonitor Pro ECG-12. It defines roles, activities, deliverables, interfaces, and control mechanisms.

2 Scope¶

Covers firmware, embedded application, algorithm components (ECG analysis), communication and data storage modules, and PC/cloud integrations (if present).

3 Normative References¶

IEC 62304:2006+A1:2015
ISO 14971:2019 (Risk Management – reference to 20.01_risk_management_file.md)
ISO 13485:2016 (QMS)
IEC 60601-1 / IEC 60601-2-25

4 Software Safety Classification¶

Preliminary classification (IEC 62304): - Critical diagnostic functions / alarm logic: Class C - Signal preprocessing and visualization: Class B - Non-safety-related UI / logging: Class A

Detailed justification provided in 30.02_software_architecture.md and SRS.

5 Roles & Responsibilities¶

Role	Responsibilities	Deputy
Software Project Manager	Overall coordination, release approval	Technical Lead
Software Architect	Architecture, interfaces, safety classification	Senior Developer
Developer	Implementation, peer reviews	-
QA / Test	Test planning, verification, traceability alignment	Test Engineer
Risk Management Officer	Align risk → requirement → measure	QA Manager

6 Lifecycle Processes (IEC 62304 Chapters)¶

6.1 Software Development Process¶

Activities: Requirements (Ch. 7), Architecture/Design (Ch. 8), Implementation (Ch. 5.5), Verification & Test (Ch. 9), Release (Ch. 5.8).

6.2 Software Maintenance Process¶

Regular assessment of bug reports, post-market data (link to 20.01_risk_management_file.md Section 9). Maintenance requests flow into backlog.

6.3 Software Risk Management Process¶

Integration with ISO 14971: Each safety-relevant software requirement receives risk ID (R###) assignment + measure reference (see Traceability Matrix 30.04_traceability_matrix.md).

6.4 Software Configuration Management¶

Git repository (branching strategy: main, feature/*, release/*). Versioning in document context via metadata script. Build artifacts (firmware/algorithms) with SemVer + Git revision.

6.5 Software Problem Resolution¶

Defect management tool: [Ticket system] (link to be added). Classification by severity & safety relevance. Critical defects → immediate risk reassessment.

7 Development Activity Planning¶

Phase	Input	Activities	Deliverables	Exit Criteria
Requirements	Stakeholder input, risk analysis	Requirements gathering, classification	SRS (version), acceptance	Complete prioritization + review
Architecture	SRS, safety classes	Decomposition, interfaces, data flow	Architecture document	Review & risk alignment complete
Implementation	Architecture, SRS	Coding, unit tests, peer review	Code, unit test reports	All critical paths tested
Verification	Code, build	System & integration tests, security tests	Test reports, coverage matrix	All risk-related tests passed
Release	Test reports, RMF alignment	Release review, sign-off	Release package, changelog	Approval granted

8 Milestones & Releases¶

Milestone	Objective	Date (planned)	Dependencies	Criteria
MVP	Basic ECG capture & display	Q1/2026	Architecture stable	Basic Class B functions verified
Feature Set v1	Complete analysis algorithms	Q2/2026	MVP	Class C components verified
Release v1.0	Market introduction	Q3/2026	Feature Set v1	All measures documented

9 Traceability Integration¶

All requirements receive unique IDs (SR-###). Linking to risks (R###) and test cases (TC-###) is maintained in 30.04_traceability_matrix.md and regularly synchronized by QA.

10 Documentation & Records¶

SRS: 30.03_software_requirements_specification.md
Architecture: 30.02_software_architecture.md
Traceability Matrix: 30.04_traceability_matrix.md
Test plans & reports: [Path to be added]
Risk Management: 20.01_risk_management_file.md

11 Quality Criteria¶

Category	Metric	Target	Measurement Point
Code Quality	Static analysis warnings	< 5 critical	CI pipeline
Test Coverage	Unit / Integration (critical modules)	≥ 80%	Test report
Defect Rate	Critical defects per release	0	Release review
Performance	Analysis algorithm time	< 2s per ECG packet	Benchmark

12 Change & Release Process¶

Changes follow: Request → impact analysis (risk/requirement) → implementation → verification → documentation update → approval. SemVer bump with automatic metadata script.

13 Annexes¶

A: Glossary
B: Role descriptions
C: Tools & infrastructure

Annex D: Change History¶

Date	Version	Author	Changes
19. November 2025	1.1.0	Unbekannt	Automatische Metadatenaktualisierung
17. November 2025	1.0.1	Unbekannt	Automatische Metadatenaktualisierung