IEC 62304 Toolkit

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Perform safety audits, create confirmation review reports of safety critical work products at specific project milestones and provide guidance to software teams on how to achieve compliance.

More Uses of the IEC 62304 Toolkit:

  • Identify and communicate appropriately quantified risks and mitigation strategies associated with regulatory strategies to stakeholders.

  • Be certain that your organization assesses project issues and develops resolutions to meet productivity, quality, and client satisfaction goals and objectives.

  • Ensure you organize; lead systems and Software Design and integration, git use of repositories to support phased in delivery in block release format of features and bug fixes in agile format.

  • Create and maintain the schedule, drive intermediate deliverables, and ensure project commitments are met.

  • Analyze test protocols to ensure that test coverage of software requirements is complete and correct.

  • Ensure you aid; solid Software Engineering fundamentals and Problem Solving skills in hardware up through system level.

  • Confirm your organization provides guidance to other associates on the application of appropriate Risk Management practices.

  • Manage work with customers, vendors, or other technical or non technical stakeholders to assess software needs and performance.

  • Establish and maintain close relationships with all functions to develop and communicate project strategies and identify issues/resolutions.

  • Identify process inefficiencies or gaps and suggest and drive improvements to help improve productivity of safety activities.

  • Confirm your organization organizes the coordination of activities with outside suppliers and consultants to ensure timely delivery and execution of project deliverables.

  • Guide: proactively provide input and judgement to influence best path forward, staying informed and aware to act, communicate and adjust during project execution.

  • Identify, deploy and monitor appropriate SMEs to ensure technical competency meets project needs.

  • Ensure the systematic and logical conversion of Customer Requirements to product specifications and post market surveillance codes.

  • Be certain that your organization devices incorporate multiple real time and non real time processors communicating over several types of interfaces.

  • Empower team members to support the completion of project goals; coach and support project members for execution excellence.

  • Make sure that your organization sets meaningful personal goals and helps others prioritize short term activities around work team/functional priorities.

  • Arrange that your Organization Designs and implements software of embedded devices and systems from requirements to production and commercial deployment.

  • Confirm your organization ensures that system improvements are successfully implemented and monitored to increase efficiency.

  • Collaborate on Failure Analysis to understand where hardware and software can fail and how to Mitigate Risks.

  • Ensure you audit; lead cross functional team to execute sustaining program activities to successful completion, on time and on budget.

  • Oversee design verification testing, manufacturing Process Validation, and test method validation activities.

  • Establish that your organization develops mechanisms for monitoring project progress and for intervention and Problem Solving with Project Managers, line managers, and clients.

  • Confirm your organization leads and ensures achievement of project objectives and milestones with initially complex or undetermined outcomes.

  • Confirm your organization applies advanced level Software Development principles to the Research and Development of Windows applications.


Save time, empower your teams and effectively upgrade your processes with access to this practical IEC 62304 Toolkit and guide. Address common challenges with best-practice templates, step-by-step Work Plans and maturity diagnostics for any IEC 62304 related project.

Download the Toolkit and in Three Steps you will be guided from idea to implementation results.

The Toolkit contains the following practical and powerful enablers with new and updated IEC 62304 specific requirements:

STEP 1: Get your bearings

Start with...

  • The latest quick edition of the IEC 62304 Self Assessment book in PDF containing 49 requirements to perform a quickscan, get an overview and share with stakeholders.

Organized in a Data Driven improvement cycle RDMAICS (Recognize, Define, Measure, Analyze, Improve, Control and Sustain), check the…

  • Example pre-filled Self-Assessment Excel Dashboard to get familiar with results generation

Then find your goals...

STEP 2: Set concrete goals, tasks, dates and numbers you can track

Featuring 997 new and updated case-based questions, organized into seven core areas of Process Design, this Self-Assessment will help you identify areas in which IEC 62304 improvements can be made.

Examples; 10 of the 997 standard requirements:

  1. Can the agile techniques, successfully used to develop user interface intensive web based software, be adapted to develop real time embedded software common in medical devices?

  2. What risk control measures are already in place, or need to be in place to assure that hazardous situations wont occur or wont lead to a harmful conclusion?

  3. How do you address security vulnerabilities with medical device/equipment vendors whose software is built on a platform that cannot be patched or updated?

  4. Does the software device provide vital signs monitoring and alarms for potentially life threatening situations in which medical intervention is necessary?

  5. Does the component distinction provide enough clarity for you to understand when software is standalone software that requires direct marking?

  6. Can verification processes or procedures be implemented outside the software item to verify its operation on a result by result basis?

  7. Do you need an update warranty or legal obligation, perhaps implied by statute, to ensure that software will be updated as needed?

  8. Which industry is best positioned to collect, integrate, and distribute health data collected from wearables and others?

  9. Are there any new or Emerging Technologies that you think will have a major impact on upcoming medical device software?

  10. What are your specification test coverage adequacy criteria and specification test generation inadequacy criteria?

Complete the self assessment, on your own or with a team in a workshop setting. Use the workbook together with the self assessment requirements spreadsheet:

  • The workbook is the latest in-depth complete edition of the IEC 62304 book in PDF containing 997 requirements, which criteria correspond to the criteria in...

Your IEC 62304 self-assessment dashboard which gives you your dynamically prioritized projects-ready tool and shows your organization exactly what to do next:

  • The Self-Assessment Excel Dashboard; with the IEC 62304 Self-Assessment and Scorecard you will develop a clear picture of which IEC 62304 areas need attention, which requirements you should focus on and who will be responsible for them:

    • Shows your organization instant insight in areas for improvement: Auto generates reports, radar chart for maturity assessment, insights per process and participant and bespoke, ready to use, RACI Matrix
    • Gives you a professional Dashboard to guide and perform a thorough IEC 62304 Self-Assessment
    • Is secure: Ensures offline Data Protection of your Self-Assessment results
    • Dynamically prioritized projects-ready RACI Matrix shows your organization exactly what to do next:


STEP 3: Implement, Track, follow up and revise strategy

The outcomes of STEP 2, the self assessment, are the inputs for STEP 3; Start and manage IEC 62304 projects with the 62 implementation resources:

  • 62 step-by-step IEC 62304 Project Management Form Templates covering over 1500 IEC 62304 project requirements and success criteria:

Examples; 10 of the check box criteria:

  1. Monitoring and Controlling Process Group: Do the partners have sufficient financial capacity to keep up the benefits produced by the programme?

  2. Procurement Management Plan: Is there a formal set of procedures supporting Issues Management?

  3. WBS Dictionary: Is cost performance measurement at the point in time most suitable for the category of material involved, and no earlier than the time of actual receipt of material?

  4. Cost Baseline: Does a process exist for establishing a cost baseline to measure IEC 62304 project performance?

  5. Cost Management Plan: How difficult will it be to do specific tasks on the IEC 62304 project?

  6. Executing Process Group: Why do you need a good WBS to use IEC 62304 Project Management software?

  7. Stakeholder Management Plan: How, to whom and how frequently will Risk status be reported?

  8. Probability and Impact Assessment: What are the levels of understanding of the future users of the outcome/results of this IEC 62304 project?

  9. Executing Process Group: Have operating capacities been created and/or reinforced in partners?

  10. Probability and Impact Assessment: Have customers been involved fully in the definition of requirements?

Step-by-step and complete IEC 62304 Project Management Forms and Templates including check box criteria and templates.

1.0 Initiating Process Group:

2.0 Planning Process Group:

3.0 Executing Process Group:

  • 3.1 Team Member Status Report
  • 3.2 Change Request
  • 3.3 Change Log
  • 3.4 Decision Log
  • 3.5 Quality Audit
  • 3.6 Team Directory
  • 3.7 Team Operating Agreement
  • 3.8 Team Performance Assessment
  • 3.9 Team Member Performance Assessment
  • 3.10 Issue Log

4.0 Monitoring and Controlling Process Group:

  • 4.1 IEC 62304 project Performance Report
  • 4.2 Variance Analysis
  • 4.3 Earned Value Status
  • 4.4 Risk Audit
  • 4.5 Contractor Status Report
  • 4.6 Formal Acceptance

5.0 Closing Process Group:

  • 5.1 Procurement Audit
  • 5.2 Contract Close-Out
  • 5.3 IEC 62304 project or Phase Close-Out
  • 5.4 Lessons Learned



With this Three Step process you will have all the tools you need for any IEC 62304 project with this in-depth IEC 62304 Toolkit.

In using the Toolkit you will be better able to:

  • Diagnose IEC 62304 projects, initiatives, organizations, businesses and processes using accepted diagnostic standards and practices
  • Implement evidence-based best practice strategies aligned with overall goals
  • Integrate recent advances in IEC 62304 and put Process Design strategies into practice according to best practice guidelines

Defining, designing, creating, and implementing a process to solve a business challenge or meet a business objective is the most valuable role; In EVERY company, organization and department.

Unless you are talking a one-time, single-use project within a business, there should be a process. Whether that process is managed and implemented by humans, AI, or a combination of the two, it needs to be designed by someone with a complex enough perspective to ask the right questions. Someone capable of asking the right questions and step back and say, 'What are we really trying to accomplish here? And is there a different way to look at it?'

This Toolkit empowers people to do just that - whether their title is entrepreneur, manager, consultant, (Vice-)President, CxO etc... - they are the people who rule the future. They are the person who asks the right questions to make IEC 62304 investments work better.

This IEC 62304 All-Inclusive Toolkit enables You to be that person.


Includes lifetime updates

Every self assessment comes with Lifetime Updates and Lifetime Free Updated Books. Lifetime Updates is an industry-first feature which allows you to receive verified self assessment updates, ensuring you always have the most accurate information at your fingertips.