- Medical Device Development
Manage Requirements & Prove Traceability with Medical Device Requirements Management Software
Manage requirements, risk, and verification for medical device and life sciences programs in one platform, with the traceability evidence reviewers expect across IEC 62304, ISO 14971, and ISO 13485.
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Industry Challenges
Meet the Challenges of Complex Medical Device Programs
Modern medical devices combine software, hardware, and biology in ways that make traceability harder to maintain by hand. With every added feature or connected capability, the design history file grows, and gaps in that traceability chain surface as delays, findings, or rework late in the program.
5–10
years to bring a Class III device to market
Complex, high-risk implantable devices such as pacemakers or neurostimulators take 5 to 10 years to design, test, and launch, compared to 18 to 24 months for many Class II devices. (Industry benchmark data)
9.4%
of industry sales consumed by the cost of poor quality
Scrap, manual rework, product rejections, and factory remediation cost medical device makers an estimated $24 billion to $33 billion annually. (McKinsey & Company)
48%
drained from the industry by recalls each year
Product recalls cost the global medical device sector an estimated $2.5 billion to $5 billion annually, including lost sales as trust erodes with healthcare providers. (Greenlight Guru)
Medical Device Engineering, End to End
AI, Traceability, and Governance in One Connected Platform
User needs, design inputs and outputs, risk controls, and verification evidence stay linked automatically, with AI catching ambiguous requirements and design history file exports generating on demand, across IEC 62304, ISO 14971, and ISO 13485 programs.
- AI-assisted authoring and impact analysis. AI flags ambiguous or untestable requirements and maps downstream impact before you accept a design change.
- Bi-directional traceability. User needs, design inputs, risk controls, and verification evidence connected in one chain, with coverage gaps flagged automatically.
- Automated governance and reporting. Generate design history file exports and compliance packages on demand from your live baseline, not a manual rebuild.
- Configuration and baseline automation. Snapshot verified design states and reuse requirement catalogs across device variants and product lines.
The Platform in Action
Medical Device Engineering, From Requirement to Design History File
Every stage of the device development lifecycle traces back to a requirement. Select a capability to see it in action.
01 · Requirements Traceability
Every Link, Bi-Directional and Current
User needs, design inputs, design outputs, and verification evidence stay connected automatically, so nothing is missed and nothing is added without justification.
- Missing links, flagged automatically. No design input goes unverified without notice.
- Matrix on demand. Export the traceability matrix instead of rebuilding it for the auditor.
Traceability Coverage
97%
Requirements traced to verification evidence
02 · ISO 14971 Risk & Safety Analysis
Catch Risk Before It's a Finding
Run hazard identification and risk control linked directly to requirements, so open risks and their mitigations stay current as the design changes.
- Risk linked to requirements. Every open hazard stays tied to its risk control.
- Residual risk, evaluated on real data. Judge risk acceptability against actual verification results, not a static estimate.
Risk Register
14
Open risks, all linked to mitigations
03 · Test Management & Verification
Verification Evidence, Ready for Review
Plan, execute, and log verification and validation results against requirements, with defects and coverage gaps surfaced as they happen, not weeks later.
- Defects auto-populated. File a defect from a failed test with full context attached.
- Coverage alerts. Know the moment a requirement has no passing test tied to it.
- AI-drafted test cases. Generate candidate test cases from requirement text, with human approval before baseline.
Test Execution
20
Tests tracked this run
04 · AI-Assisted Requirements Authoring
Write Requirements That Hold Up in Review
Author requirements with structured attributes and get flagged the moment language is ambiguous, inconsistent, or untestable.
- AI-assisted quality checks. AI flags ambiguous, inconsistent, or untestable language as requirements are written.
- Document-style authoring. Write and edit without losing traceability context.
Requirements Quality
100 %
Requirements checked before baseline
05 · Audit & Design History File Reporting
Design History File Evidence, Generated On Demand
Produce the design history file and compliance packages reviewers and auditors expect, straight from your live project data.
- Standards-aligned exports. IEC 62304, ISO 14971, ISO 13485, and more, from the same data.
- Submission-ready documents. Formatted for regulatory review, not just internal use.
Compliance Coverage
100 %
Requirements with certification evidence ready
Domains We Serve
Purpose-Built for Every Medical Device Domain
The same connected data model adapts to the specific compliance and traceability needs of each domain.
Complex Medical Devices
Manage requirements, risk, and verification for every device class, with full traceability and compliance support.
- Design controls structured around FDA and ISO 13485 expectations
- Hazard-to-control traceability built into the data model
- Native support for IEC 62304, ISO 14971, and 21 CFR Part 11
In Vitro Diagnostics
Support for both traditional IVDs and software-driven diagnostic devices, aligned to evolving regulatory expectations.
- Traceability structured for IVDR and FDA review
- Risk analysis integrated with assay and device requirements
- Reusable templates for connected and point-of-care devices
Software as a Medical Device
Move faster on SaMD with an IEC 62304-aligned structure that fits agile delivery without losing traceability.
- Agile workflows mapped to software safety classification
- Cybersecurity risk analysis in the same hazard structure
- AI-assisted quality checks before every baseline
Combination Products
Coordinate requirements and traceability across drug, device, and biologic components in one connected record.
- Unified traceability across constituent parts
- Risk management that spans device and drug considerations
- Structured documentation for combination product submissions
Emerging Life Sciences
Scale traceability and documentation into biologics, veterinary, and consumer health-adjacent product lines.
- Flexible requirement structures for evolving regulatory paths
- Reusable libraries across adjacent product categories
- Documentation that scales from research use to commercial launch
Compliance Depth
Built for IEC 62304, ISO 14971, ISO 13485, and More
One connected data model supports every standard your medical device programs need to certify against.
| Standard | What It Requires | How Visure Helps |
|---|---|---|
| IEC 62304 | Software lifecycle processes for medical device software, with safety classification (A, B, C) driving the required rigor. | Software safety class workflows built in, with requirements, architecture, and verification records linked to the classification assigned. |
| ISO 14971 | Risk management across the device lifecycle, covering hazard identification, risk estimation, and risk control. | Hazard-to-control traceability integrated with device requirements, with residual risk evaluated against real verification evidence. |
| ISO 13485 | Quality management system requirements for medical device organizations, including design controls and change control. | Design history file structure built into the data model, with design change documentation and verification records maintained automatically. |
| 21 CFR Part 11 | Electronic records and signatures for FDA-regulated environments, with individual user authentication and audit trails. | Electronic signature workflows, an immutable audit trail, and access-controlled record management out of the box. |
| FDA QMSR | The FDA's Quality Management System Regulation, incorporating ISO 13485 by reference while retaining FDA-specific requirements. | Design control structure that maps to both ISO 13485 and FDA-specific expectations, so the same data model supports both. |
| IVDR | EU regulatory framework for in vitro diagnostic devices, covering performance evaluation and technical documentation. | Traceability structured to support IVDR technical documentation, with risk analysis integrated into assay and device requirements. |
Everything Included
One Platform, Every Medical Device Capability
All part of the same governed data model as your requirements, risk, and verification evidence.
Design Baseline & Snapshotting
Snapshot verified requirement sets at each milestone and compare versions instantly, so design history stays intact as the device changes.
Collaborative Reviews & E-Signatures
Route requirements through structured design review workflows, with 21 CFR Part 11 electronic signatures on every sign-off.
ReqIF & Office Import/Export
Move data in and out via ReqIF, IBM DOORS, and Microsoft Word & Excel.
Custom Compliance Reporting
Generate IEC 62304, ISO 14971, and ISO 13485 evidence packages formatted to what your notified body or FDA reviewer actually asks for.
AI-Powered Change Impact Analysis
AI maps every downstream item a design change affects before you accept it.
AI Engineering Intelligence
Visure’s AI flags ambiguous or untestable requirement language and drafts candidate verification test cases, with every output held for human review before baseline.
ISO 14971 Risk Management
Hazard identification, risk estimation, and risk control, linked directly to the requirements and design features that address them.
Multi-Product Reuse
Run one program across device variants and product lines from a single connected data model, no duplicate requirement sets per SKU.
INTEGRATIONS
Works With Your Existing Medical Device Engineering Toolchain
Moving to structured requirements management doesn’t mean ripping out the tools your team already relies on. Visure connects directly to the PLM, ALM, and engineering tools medical device teams already use.
1,000+ Highly Regulated Organizations Trust Visure
Full ROI within the first year
0
%
Saved on average per project
+$
0
K
Reduction in time to market
0
%
Reduction in audit preparation time
0
%
Reduction in rework per project
0
%
What industry professionals say about us
“Visure tools helped identify deficiencies in our traceability from using traditional spreadsheets for a mission critical customer.”
“The quicker the developer can demonstrate the proof of the completed reviews, the more credibility they show to the certification authorities such as FAA and EASA.”
“Visure Requirements ALM Platform really simplified the project traceability and impact analysis process, that used to be very time consuming before Visure”
"Visure is stable and HMI team started using this effectively. Now we are planning to expand Visure usage to other departments. Also, I am planning to use other features in Visure and adopt it for the project accordingly.
The support from Visure team is outstanding. I haven’t come across this kind of support from any other tool vendors. I mean it. Convey our thanks and appreciation to the entire Visure team."
"The ALM tool is truly very valid when it comes to traceability and management of products, in particular with reference to ASPICE. The AI add-on is very well integrated and useful for speeding up work, provided that the automatically produced results are appropriately reprocessed."
As posted in G2, SoftwareReviews and TrustRadius.
Explore More
Medical Device Resources from Visure
The Ultimate IEC 62304 Handbook
Understand software lifecycle requirements, safety classifications, risk management, and traceability practices.
Requirements Management in Medical Device Development
Learn how to connect user needs, design inputs, risks, and verification evidence throughout development.
AI/ML In MedTech & Healthcare
How AI-driven change control can help you manage changes faster, safer, and with full audit readiness.
Medical Device FAQ
Frequently Asked Questions
Can’t find an answer? Contact our team →
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See Medical Device Compliance Come Together
Teams on Visure save an average of $125K per project, reach market 35% faster, and cut audit prep time in half. Start your 14-day free trial, all features included, no credit card required.
- All 9 platform modules requirements, traceability, risk, test, change, compliance, cybersecurity, Word & Excel sync, and AI intelligence
- Medical device traceability built in requirements, risk, and verification evidence linked automatically
- Standards-aligned workflows IEC 62304, ISO 14971, ISO 13485, and 21 CFR Part 11
- Live integrations Jira, Azure DevOps, GitLab, PTC Windchill, and 50+ more
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