TRACEABILITY FOR MEDICAL DEVICE ENGINEERING
Build medical devices with complete lifecycle traceability
Medical device development depends on more than meeting regulatory expectations. Engineering teams must maintain clear connections between user needs, requirements, risk controls, verification activities, reviews, and design changes throughout the product lifecycle.
THE CHALLENGE
Managing change without losing compliance evidence
Disconnected development artifacts
Preparing for audits and regulatory reviews
X-TRACE FOR MEDICAL DEVICES
Streamline design controls, risk mitigations, and V&V execution
Manage requirements across the development lifecycle
Establish a structured foundation for medical device development by managing requirements at multiple levels while maintaining clear relationships between user needs, system requirements, software requirements, and design outputs.
Manage requirements across multiple levels of development
Create and maintain structured traceability relationships
Version control and baselining across interations and change orders
Support collaboration across engineering, quality, and regulatory teams
ID & Naming
Layers
Relationships
Summary
ID & Naming Conventions
Define the primary identifier standards and digit constraints that will be automatically generated and validated for artifacts within this project.
Project Type
Hardware & Firmware Development
Determines default asset profiles and schema types.
ID Prefix
HWDEV
Requirement ID Digits
4
Number of digits for requirement IDs (1-9).
Test ID Digits
3
Number of digits for test IDs (1-9).
Draft
Version
1.0.1
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ID
Origin
Requirement
Block ID
Block Name
Checks
AR‑01
HW-01
HW-02
The architecture shall support both streaming and memory‑to‑memory image processing modes.
A01
Modal
REQ
F
B
VER
F
B
AR-02
HW-03
The architecture shall include an image processing pipeline capable of applying lens correction and geometric transforms.The architecture shall include an image processing pipeline capable of applying lens correction and geometric transforms.The architecture shall include an image processing pipeline capable of applying lens correction and geometric transforms.
B02
Pipeline
REQ
F
B
VER
F
B
AR-03
HW-04
The architecture shall support one or more scalable image scaling paths that can operate independently.
C01
Scaler
REQ
F
B
VER
F
B
AR-04
HW-05
The architecture shall support direct memory access for image input and output.
D04
Sens_4
REQ
B
VER
F
B
AR-05
HW-02
HW-04
The architecture shall allow configurable instantiation of processing functions to support different system configurations.
F01
Configurator
Last updated 10 Apr 2026, 10:55 AM
Connect verification activities to requirements
Demonstrate that requirements have been reviewed, verified, and validated with traceable evidence.
By linking requirements to verification activities, teams gain clearer visibility into coverage, readiness, and project status.
Link requirements directly to verification and validation activities
Generate and manage test cases from requirements
Run peer reviews and verification reviews within the workflow
Bidirectional linking between technical specifications, verification test cases, and clinical validation evidence
See what changed, and what it affects.
Evaluate the blast radius of engineering updates. Compare versions, identify impacted relationships and move changes through structured peer and verification reviews.
Controlled versions and project history
Real-time impact analysis showing affected downstream requirements, risk mitigations, and V&V tests.
Baseline management and sign-off
Audit log capturing full change history, author metadata, and review approvals.
Draft
Version
1.0.1
2
2
0
Add requirement
Filter
6
Sort
Search...
Showing
05
of 453
ID
Origin
Requirement
Block ID
Block Name
Checks
AR‑01
HW-01
HW-02
The architecture shall support both streaming and memory‑to‑memory image processing modes.
A01
Modal
REQ
F
B
VER
F
B
AR-02
HW-03
The architecture shall include an image processing pipeline capable of applying lens correction and geometric transforms.The architecture shall include an image processing pipeline capable of applying lens correction and geometric transforms.The architecture shall include an image processing pipeline capable of applying lens correction and geometric transforms.
B02
Pipeline
REQ
F
B
VER
F
B
AR-03
HW-04
The architecture shall support one or more scalable image scaling paths that can operate independently.
C01
Scaler
REQ
F
B
VER
F
B
AR-04
HW-05
The architecture shall support direct memory access for image input and output.
D04
Sens_4
REQ
B
VER
F
B
AR-05
HW-02
HW-04
The architecture shall allow configurable instantiation of processing functions to support different system configurations.
F01
Configurator
Last updated 10 Apr 2026, 10:55 AM
medical STANDARDS
Support the workflows behind medical compliance.
Standard
What It Requires
How X-Trace Helps
ISO 13485
Medical device quality management system requirements for process control, design change management, and complete Design History File (DHF) compilation.
Trace structures requirements, reviews, verification and project responsibilities within a consistent workflow. Controlled versions, baselines, review records and sign-off help teams maintain an organized development history and support audit-ready evidence.
ISO 14971
A systematic risk-management process covering identification and evaluation of risks, implementation of risk controls, and monitoring their effectiveness throughout the medical-device lifecycle.
Trace helps connect requirements and verification activities so teams can maintain visibility into the engineering relationships. Impact Analysis and controlled changes help identify downstream relationships when requirements evolve.
IEC 62304
Software lifecycle requirements including software requirements management, verification, change management, and traceability throughout development and maintenance.
Trace provides structured requirement hierarchies, requirement-to-verification relationships, forward and backward trace checks, reviews, version comparison and controlled baselines to help maintain software lifecycle traceability.
EU MDR 2017/745
Requires detailed technical documentation, methods and evidence which demonstrate conformity, risk-management information, and product verification and validation results.
Trace maintains continuous, updateable technical documentation and impact analysis workflows, helping teams maintain the relationships needed to demonstrate how requirements are addressed and verified.
FDA 21 CFR Part 820
Comprehensive design controls mandating clear alignment between user needs, design inputs, design outputs, design verification, design validation, and design changes.
Trace maintains live, bidirectional traceability across the entire design lifecycle, defined responsibilities, reviews, verification relationships, version control, baselines and project sign-off.