IEC 62304 Toolkit

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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 993 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 993 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. How is ai use in medical practice distinguished from big data analytics applications for health care delivery and population health?

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

  9. Do you need immediate response to keep your imaging systems, patient monitors, and medical equipment performing at full capacity?

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


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 993 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. Cost Management Plan: Are changes in deliverable commitments agreed to by all affected groups & individuals?

  2. Project Portfolio management: Why would the work force want to know the force rank order of the portfolio?

  3. Source Selection Criteria: What aspects should the contracting officer brief the IEC 62304 project on prior to evaluation of proposals?

  4. Lessons Learned: Did the delivered product meet the specified requirements and goals of the IEC 62304 project?

  5. Scope Management Plan: Is there a formal set of procedures supporting Stakeholder Management?

  6. Probability and Impact Matrix: Costs associated with late delivery or a defective product?

  7. Project or Phase Close-Out: Did the delivered product meet the specified requirements and goals of the IEC 62304 project?

  8. Procurement Audit: Is there no evidence that the consultants participating in the IEC 62304 project design released information to contractors competing for the prime contract?

  9. Requirements Management Plan: Which hardware or software, related to, or as outcome of the IEC 62304 project is new to your organization?

  10. Risk Audit: Are you aware of the industry standards that apply to your operations?

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

1.0 Initiating Process Group:

  • 1.1 IEC 62304 project Charter
  • 1.2 Stakeholder Register
  • 1.3 Stakeholder Analysis Matrix


2.0 Planning Process Group:

  • 2.1 IEC 62304 project Management Plan
  • 2.2 Scope Management Plan
  • 2.3 Requirements Management Plan
  • 2.4 Requirements Documentation
  • 2.5 Requirements Traceability Matrix
  • 2.6 IEC 62304 project Scope Statement
  • 2.7 Assumption and Constraint Log
  • 2.8 Work Breakdown Structure
  • 2.9 WBS Dictionary
  • 2.10 Schedule Management Plan
  • 2.11 Activity List
  • 2.12 Activity Attributes
  • 2.13 Milestone List
  • 2.14 Network Diagram
  • 2.15 Activity Resource Requirements
  • 2.16 Resource Breakdown Structure
  • 2.17 Activity Duration Estimates
  • 2.18 Duration Estimating Worksheet
  • 2.19 IEC 62304 project Schedule
  • 2.20 Cost Management Plan
  • 2.21 Activity Cost Estimates
  • 2.22 Cost Estimating Worksheet
  • 2.23 Cost Baseline
  • 2.24 Quality Management Plan
  • 2.25 Quality Metrics
  • 2.26 Process Improvement Plan
  • 2.27 Responsibility Assignment Matrix
  • 2.28 Roles and Responsibilities
  • 2.29 Human Resource Management Plan
  • 2.30 Communications Management Plan
  • 2.31 Risk Management Plan
  • 2.32 Risk Register
  • 2.33 Probability and Impact Assessment
  • 2.34 Probability and Impact Matrix
  • 2.35 Risk Data Sheet
  • 2.36 Procurement Management Plan
  • 2.37 Source Selection Criteria
  • 2.38 Stakeholder Management Plan
  • 2.39 Change Management Plan


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

 

Results

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.