Can the analysis be signed electronically?

Yes. Electronic signatures are legally enforceable under the ESIGN Act (15 U.S.C. §7001) and intrastate under UETA where adopted. Ensure intent, consent, attribution, and reproducible record retention to meet the four-part legal test.

Is notarization or witness required for this document?

Typically no. Internal hazard analyses usually do not require notarization or witnesses unless a specific contract, agency, or state rule mandates it. Confirm with contract terms or the applicable regulatory authority.

What level of signer authentication is recommended?

Use at least email authentication with organizational SSO; for higher assurance or regulated submissions, require multi-factor authentication or platform features that meet 21 CFR Part 11 controls.

How should I store the signed document?

Store signed artifacts in a controlled repository with TLS 1.2/1.3 transport and AES-256 at-rest encryption. Maintain an audit trail and access controls to support audits.

Who is authorized to sign the analysis?

Typical signatories are the project manager, safety lead, and quality/regulatory approver. The signatory list should be defined in project governance and recorded in the document.

How often must the analysis be updated?

Update whenever design, intended use, or operating environment changes, and at formal milestones such as design freeze, verification entry, and post-release reviews.

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Project Management Device Software Hazard Analysis

Project Management Device Software Hazard Analysis

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What the Project Management Device Software Hazard Analysis Is

A Project Management Device Software Hazard Analysis documents identified hazards, their causes, and planned mitigations within a device software project lifecycle. It links risk analysis to project tasks, design controls, verification activities, and release criteria. For regulated medical device projects this analysis supports design history files and risk management traces, and it informs scheduling, resource allocation, and regulatory submissions.

Why this Analysis Matters for Device Software Projects

A focused hazard analysis reduces downstream rework, clarifies testing requirements, and provides audit evidence for design reviews and regulatory bodies. It helps teams prioritize fixes, schedule verification, and demonstrate that risks have been identified and mitigated prior to release.

Who Prepares and Reviews a Hazard Analysis

Cross-functional review cycles ensure the document supports both project control and compliance obligations throughout development.

Project Managers: Maintain the hazard register, assign remediation tasks, and monitor timelines across design and verification activities.
Software Engineers: Identify failure modes, implement mitigations, and provide evidence for unit and integration testing.
Regulatory / QA Specialists: Ensure alignment with regulatory expectations, maintain traceability, and prepare documentation for audits and submissions.

Essential Components to Include in a Professional Analysis

A complete hazard analysis ties identified hazards to risk assessments, control measures, verification evidence, and project milestones so stakeholders can act and auditors can verify compliance.

Scope

Define the device, software versions, intended use, user profiles, and operating environments so hazard identification is bounded and traceable to requirements.

Hazard Identification

List each hazard with a short description, potential causes, affected functions, and how it could lead to harm under normal and fault conditions.

Risk Assessment

Record severity, probability, and risk score using your organization's matrix; note acceptance criteria and required residual risk level.

Mitigations and Controls

Specify design, software, labeling, or procedural controls, who is responsible, planned completion date, and how the control reduces risk.

Verification Evidence

Reference test cases, traceability to requirements, verification results, and where artifacts are stored for audit (test reports, logs, code reviews).

Project Traceability

Link hazards to backlog items, change requests, release milestones, and design reviews to demonstrate that risk work is integrated into project management.

Required Fields and Core Data Elements

Document Title: Project-specific analysis name

Version History: Version number and change date

Hazard ID: Unique identifier

Risk Rating: Severity and probability

Mitigation Owner: Assigned individual or team

Verification Link: Reference to test artifacts

Step-by-Step: Completing the Hazard Analysis

Follow this sequence to create a defensible, auditable hazard analysis that aligns with project schedules and verification activities.

01

Identify Scope: Define device, software modules, and use conditions.
02

List Hazards: Capture all plausible failure modes and operational hazards.
03

Assess Risk: Apply the organizational risk matrix to score each hazard.
04

Assign Controls: Document mitigations, owners, and verification tasks.

Configure an Online Workflow for the Analysis

Set up a repeatable digital workflow so updates, approvals, and evidence are captured automatically and stored in a controlled repository.

Field	Configuration
Document Version	Auto-increment on save
Reviewer Role	Require sign-off by QA and Safety
Signer Authentication	Email + company SSO
Archive Location	Controlled document management system

Digital Delivery and Signing Considerations

Platforms with integration options (document repositories, PLM, ticketing systems) reduce manual handoffs and preserve traceability across the lifecycle.

Authentication: Email plus optional MFA
Audit Trail: IP, timestamp, and action log
Storage: AES-256 encrypted at rest

Where to Send the Completed Analysis and Who Receives It

A clear routing plan ensures the analysis reaches project reviewers, quality, and regulatory teams and that signed records are archived properly.

Project Repository: Store the signed analysis with source code and requirements.
Quality Team: Provide for audit and design history file inclusion.
Regulatory Affairs: Attach to regulatory submissions or premarket dossiers.
Stakeholder Distribution: Notify owners and verification teams of required tests.

Typical Timelines and Milestones to Track

Plan hazard analysis activities to align with key design and release milestones to avoid schedule slips and late discovery of systemic risks.

Initial Analysis:

Completed during concept or requirements phase

Design Freeze Review:

Update and finalize before design freeze

Verification Entry:

Mitigations defined prior to verification testing

Release Approval:

All high-risk items mitigated before release

Post-Release Review:

Conduct within 3–6 months of deployment

Common Mistakes That Cause Delays or Nonconformities

Narrow hazard scope: failing to include all modes and operating environments leads to missed mitigations during verification.
Poor traceability: not linking hazards to requirements, tickets, or tests makes audits and root-cause analysis time-consuming.
Vague mitigations: controls described generically without acceptance criteria cause review cycles and unverifiable fixes.
Stale documents: not updating the analysis after code changes or field issues results in inaccurate residual risk assessments.

Consequences of an Incorrect or Incomplete Analysis

Regulatory Delay: Longer review cycles

Recall Risk: Potential market withdrawal

Nonconformity: Audit findings and CAPAs

Patient Harm: Safety incidents

Liability Exposure: Legal and financial risk

Rework Cost: Increased development effort

Comparison: eSignature Options for Signing and Storing Hazard Analyses

Select a signing platform that supports audit trails, secure storage, and any regulatory addenda required; the table compares common vendor baseline features and pricing.

	signNow	DocuSign	Adobe Sign	PandaDoc	HelloSign
Starting Price	$8/user/mo	$15/user/mo	$14/user/mo	$19/user/mo	$15/user/mo
Free Trial	7-day free trial	Varies by plan	Varies by plan	Varies by plan	Varies by plan
Bulk Send	Yes	Yes	Yes	Yes	Yes
Audit Trail	Yes	Yes	Yes	Yes	Yes
HIPAA Compliant	Yes	Yes	Yes	No	No
Envelope Cap	No envelope cap	100 envelopes/user/year	Varies by plan	Varies by plan	Varies by plan

Frequently Asked Questions About the Hazard Analysis

Answers to common questions about legal validity, digital signatures, storage, and approval authority for device software hazard analyses.

Need help? Contact support

Can the analysis be signed electronically?
Yes. Electronic signatures are legally enforceable under the ESIGN Act (15 U.S.C. §7001) and intrastate under UETA where adopted. Ensure intent, consent, attribution, and reproducible record retention to meet the four-part legal test.
Is notarization or witness required for this document?
Typically no. Internal hazard analyses usually do not require notarization or witnesses unless a specific contract, agency, or state rule mandates it. Confirm with contract terms or the applicable regulatory authority.
What level of signer authentication is recommended?
Use at least email authentication with organizational SSO; for higher assurance or regulated submissions, require multi-factor authentication or platform features that meet 21 CFR Part 11 controls.
How should I store the signed document?
Store signed artifacts in a controlled repository with TLS 1.2/1.3 transport and AES-256 at-rest encryption. Maintain an audit trail and access controls to support audits.
Who is authorized to sign the analysis?
Typical signatories are the project manager, safety lead, and quality/regulatory approver. The signatory list should be defined in project governance and recorded in the document.
How often must the analysis be updated?
Update whenever design, intended use, or operating environment changes, and at formal milestones such as design freeze, verification entry, and post-release reviews.

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Project Management Device Software Hazard Analysis