See a medical device Hazard Analysis example, built with you

rmForge is a working session, not a self-serve form. You bring your device documents, we run the analysis with you on a screen share, and your review-ready ISO 14971:2019 Hazard Analysis workbook is delivered on payment. From the finished Hazard Analysis, rmForge can then build a Design or Process Failure Mode and Effects Analysis (FMEA).

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Watch a session

A recorded working session on a cobalt chromium coronary stent from a fictional client: the six questionnaire steps, the pipeline run, and the drafted workbook. 4 minutes 25 seconds. Click a chapter to jump to it.

Mike Reo walks a bare metal coronary stent from a fictional client, X Vascular, through the six rmForge questionnaire steps: device identification and the Food and Drug Administration (FDA) product code, what to generate, which design documents exist, the Instructions for Use upload, requirement numbering and Risk Control Measure prefixes, and sign off. rmForge forges the ISO 14971 Hazard Analysis, and the drafted workbook is opened column by column, from Risk ID to Risk Level and the Risk Control Measure recommendations, then tab by tab.

4 minutes 25 seconds, with sound. Captions from the CC control. Outputs shown are draft and require qualified review.

Prefer to read? Read the full transcript.

How a working session runs

01

Tell us about your device

Create an account and answer a short questionnaire: device, classification, stage, timeline. About two minutes.

02

Book your working session according to qualification

Pick a time on the rmForge calendar and we can run an analysis.

03

Run the analysis together

On a screen share, we walk your device through the rmForge questionnaire and generate hazard lines traceable to your Product Requirements and User Needs if provided.

04

Review a few lines together

We read a drafted portion together: hazards, hazardous situations, harms, severity, and probability. Risk levels come from fixed lookup tables, not model guesses.

05

Decide on Services and Payment: Leave with the workbook

On payment, you receive a Hazard Analysis workbook by email and in your dashboard. Outputs are draft and require qualified cross functional human review.

A sample of the finished work

Below is an excerpt from a completed Hazard Analysis for a bare metal coronary stent, a synthetic test device. The finished workbook carries 32 columns per row; twenty-four are shown here.

Design controls

In a complete Hazard Analysis, each Risk Control Measure (RCM) links by number to a requirement (design input), an implementation (design output), and a verification (design verification and validation, process validation, or inspection). Break the chain anywhere and the control is unproven, which puts patients at risk.

  1. Design inputPR-0001-004Stent surface finish optimized to minimize thrombogenicity and neointimal hyperplasia response
  2. Design outputCP-00024Surface finish and biocompatibility specification, Component
  3. VerificationTR-00073Surface roughness measurement

From row HZ-0046. Example numbering.

Risk LevelLowMediumHighUnacceptableColors match the delivered workbook.

P1: probability the hazardous situation occurs. P2: probability it leads to harm. S: Severity of Harm. Po: Probability of Harm Occurrence.

HZ-0046High
Potential or stored energyCompression
Intended UseNormal

Foreseeable Sequence of Events

  1. 1. Neointimal hyperplasia develops within the stented segment over weeks to months
  2. 2. Neointimal tissue compresses the stent lumen, progressively reducing coronary blood flow

Hazardous Situation

Patient coronary artery lumen progressively narrowed by neointimal tissue growth within the stented segment

Harm

Myocardial ischemiaP1 4 P2 3 S 4 Po 3

Risk Control Measure Option Categories

  1. 1. Design
  2. 2. Information for Safety

RCM RequirementsDesign inputs

  • PR-0001-004: Stent surface finish optimized to minimize thrombogenicity and neointimal hyperplasia response
  • PR-0006-002: IFU recommends post-procedural antiplatelet therapy and clinical follow-up to monitor for restenosis

ImplementationDesign outputs

  • CP-00024 Surface finish and biocompatibility specification, Component
  • IFU0010, Instructions for Use

VerificationVerification and validation

  • TR-00073 Surface roughness measurement
  • TR-00074 Hemocompatibility test
  • TR-00075 Labeling review for follow-up recommendations

Residual risk

Rev P1
TBD
Rev P2
TBD
Rev S
TBD
Rev Po
Revised Harm
Myocardial ischemia
Residual Risk
New Risk
N
HZ-0109Medium
DeliveryRate
Misuse: Use ErrorFault

Foreseeable Sequence of Events

  1. 1. Balloon inflation rate exceeds the recommended range
  2. 2. Stent expands asymmetrically against the vessel wall

Hazardous Situation

Patient coronary artery wall subjected to asymmetric radial force during stent deployment

Harm

Coronary dissectionP1 2 P2 3 S 4 Po 2

Risk Control Measure Option Categories

  1. 1. Information for Safety

RCM RequirementsDesign inputs

  • PR-0006-005: IFU specifies recommended balloon inflation rate and technique to achieve uniform stent expansion

ImplementationDesign outputs

  • IFU0010, Instructions for Use

VerificationVerification and validation

  • TR-00185 Human factors validation of deployment procedure instructions

Residual risk

Rev P1
TBD
Rev P2
TBD
Rev S
TBD
Rev Po
Revised Harm
Coronary dissection
Residual Risk
New Risk
N
HZ-0072Medium
Biological agentsViruses
Intended UseFault

Foreseeable Sequence of Events

  1. 1. Viral contamination persists on raw material or manufacturing environment surface
  2. 2. Terminal sterilization process fails to achieve adequate viral inactivation

Hazardous Situation

Patient bloodstream exposed to viral agents on stent surface during coronary implantation

Harm

Viral infectionP1 1 P2 2 S 4 Po 1

Risk Control Measure Option Categories

  1. 1. Process

RCM RequirementsDesign inputs

  • PR-0003-006: Manufacturing environment controlled per ISO 14644 cleanroom classification with validated cleaning and disinfection procedures.
  • PR-0003-007: Incoming raw material supplier qualification includes viral safety assessment.

ImplementationDesign outputs

  • TBD by client Cleanroom environmental control work instruction, Work Instruction
  • TBD by client Supplier qualification procedure for raw materials, Work Instruction

VerificationVerification and validation

  • TR-00121 Environmental monitoring and particulate count validation
  • TR-00122 Supplier audit and certificate of analysis review

Residual risk

Rev P1
TBD
Rev P2
TBD
Rev S
TBD
Rev Po
Revised Harm
Viral infection
Residual Risk
New Risk
N
HZ-0064Low
Chemical agents - pyrogenicPyrogenic
Intended UseFault

Foreseeable Sequence of Events

  1. 1. Pyrogenic material contaminates stent surface during manufacturing
  2. 2. Terminal sterilization fails to eliminate non-endotoxin pyrogenic substances

Hazardous Situation

Patient bloodstream exposed to pyrogenic material on stent surface during coronary implantation

Harm

FeverP1 2 P2 3 S 2 Po 2

Risk Control Measure Option Categories

  1. 1. Process
  2. 2. Design

RCM RequirementsDesign inputs

  • PR-0003-003: Material-mediated pyrogen testing per ISO 10993-11 or USP <151> on finished stent.
  • PR-0003-004: Manufacturing process includes validated depyrogenation step for stent components.

ImplementationDesign outputs

  • TBD by client Pyrogen testing work instruction, Work Instruction
  • CP-00030 Depyrogenation process specification, Component

VerificationVerification and validation

  • TR-00104 Pyrogen test per ISO 10993-11
  • TR-00105 Depyrogenation efficacy validation

Residual risk

Rev P1
TBD
Rev P2
TBD
Rev S
TBD
Rev Po
Revised Harm
Fever
Residual Risk
New Risk
N
TBD by client marks where your own design output or test report number goes.Residual risk is set by your team after the controls are verified. Rev P1, Rev P2 and Rev S start as TBD, Rev Po and Residual Risk stay blank until those are filled, Revised Harm starts as the original harm, and New Risk starts at N.

Risk Level lookup

Each sample row sits in its cell. Same table, every row.

Excerpt from a real rmForge output: 4 rows and 24 of the workbook’s 32 columns. The requirement, implementation, and verification numbers are examples of how the links read once your User Needs list, Instructions for Use, and part and test numbering are set up. This run had no design documents, so its workbook reads “TBD by client” for implementation and verification. Outputs are draft and require qualified human review before any regulatory submission.

  1. Risk IDs follow the workbook’s row order. Revisions match rows by content, and each change is listed on a Change Summary tab.
  2. Each line is written for a reviewer: clear, consistently structured language and controlled vocabulary, ready for your quality system after cross functional review.
  3. Severity and probability map to a Risk Level through fixed lookup tables, shown on the workbook’s Risk Region tab. Check them against your risk management plan.

Ready to see it on your device?

Sign up, answer a short questionnaire, and book a working session. We build your first Hazard Analysis with you.

Get started

Questions first? Read the FAQ, read what a Hazard Analysis is, or see how it differs from an FMEA.