ISO 14971 Toolkit

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Use any risk management process without in depth understanding of your products and process, probability and frequencies

 

Do risk control measures introduce new hazards or affect other hazards?

Are new hazards introduced or existing risks affected due to risk controls?

What is difficult with the new risk management process?

Can a change to the environmental influences cause the medical device to pose hazards for the user?

Is the medical device intended to be routinely cleaned and disinfected by the user?




...Find the answers to these, and more, questions with this ISO 14971 Toolkit:

  • Build principles into your process and realize tangible improvements.
  • Boil down to key release tests.
  • Demonstrate a lower level of risk compared to the standard.
  • Boil such down to key release tests.
  • Manage risk without post production measurement.
  • Manage translation of your web site content.
  • Protect your intellectual property abroad.
  • Link executive dashboard metrics to process level performance metrics.
  • Raise your organizations profile within the device industry.



HOW THIS TOOLKIT WORKS:

Save time, empower your teams and effectively upgrade your processes with access to this practical ISO 14971 Toolkit and guide. Address common challenges with best-practice templates, step-by-step work plans and maturity diagnostics for any ISO 14971 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 ISO 14971 specific requirements:


STEP 1: Get your bearings

Start with...

  • The latest quick edition of the ISO 14971 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 904 new and updated case-based questions, organized into seven core areas of process design, this Self-Assessment will help you identify areas in which ISO 14971 improvements can be made.

Examples; 10 of the 904 standard requirements:

  1. Is the source hazardous with respect to the product function, application, environment, uses, users and others involved, exposed, having access, or otherwise affected?

  2. Do the information materials supplied by the manufacturer correspond with the contents of the report and are all discrepancies identified in the reports conclusions?

  3. Does increasing influence of sensor output data on clinical decision making affect benefit/risk and therefore the level of verification and validation necessary?

  4. How does the Benefit/Risk evaluation change as the capability of the technology starts with monitoring and evolves to diagnostics and active treatment?

  5. Are there any especially significant events, coverage, retention or accounting changes that have occurred that must be considered when making analyses?

  6. Where is your organization on the curve; what is it doing to reinvent itself and ensure it stays in the zone of rapid growth for as long as possible?

  7. Which analysis method is MOST appropriate to prioritize risk and monitor the effectiveness of risk control activities for a medical device?

  8. How do you use any risk management process without in depth understanding of your products and process, probability and frequencies?

  9. Which specific engineering approaches have already been applied to the development of crisis and disaster management systems?

  10. Do the device benefits and risks include effects on the health related quality of life or other patient reported outcomes?


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 ISO 14971 book in PDF containing 904 requirements, which criteria correspond to the criteria in...

Your ISO 14971 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 ISO 14971 Self-Assessment and Scorecard you will develop a clear picture of which ISO 14971 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 ISO 14971 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 ISO 14971 projects with the 62 implementation resources:

  • 62 step-by-step ISO 14971 Project Management Form Templates covering over 1500 ISO 14971 project requirements and success criteria:

Examples; 10 of the check box criteria:

  1. Probability and Impact Matrix: What will be the impact or consequence if the risk occurs?

  2. Procurement Audit: Are there appropriate controls in place to ensure that the procurement ISO 14971 project complies with relevant legislation?

  3. Executing Process Group: Would you rate yourself as being risk-averse, risk-neutral, or risk-seeking?

  4. Responsibility Assignment Matrix: Are there any drawbacks to using a responsibility assignment matrix?

  5. Change Request: What is the relationship between requirements attributes and reliability?

  6. Roles and Responsibilities: Once the responsibilities are defined for the ISO 14971 project, have the deliverables, roles and responsibilities been clearly communicated to every participant?

  7. Schedule Management Plan: Is a pmo (ISO 14971 project management office) in place and provide oversight to the ISO 14971 project?

  8. Risk Audit: For this risk .. what do you need to stop doing, start doing and keep doing?

  9. Duration Estimating Worksheet: For other activities, how much delay can be tolerated?

  10. Monitoring and Controlling Process Group: What good practices or successful experiences or transferable examples have been identified?

 
Step-by-step and complete ISO 14971 Project Management Forms and Templates including check box criteria and templates.

1.0 Initiating Process Group:

  • 1.1 ISO 14971 project Charter
  • 1.2 Stakeholder Register
  • 1.3 Stakeholder Analysis Matrix


2.0 Planning Process Group:

  • 2.1 ISO 14971 project Management Plan
  • 2.2 Scope Management Plan
  • 2.3 Requirements Management Plan
  • 2.4 Requirements Documentation
  • 2.5 Requirements Traceability Matrix
  • 2.6 ISO 14971 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 ISO 14971 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 ISO 14971 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 ISO 14971 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 ISO 14971 project with this in-depth ISO 14971 Toolkit.

In using the Toolkit you will be better able to:

  • Diagnose ISO 14971 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 ISO 14971 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 ISO 14971 investments work better.

This ISO 14971 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.





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CONTENTS:


Checklists:


Checklists:ISO 14971 Checklist Report on PRODUCT.pdf

Checklists:ISO 14971 Checklist Report on DESIGN.pdf

Checklists:ISO 14971 Checklist Report on RISK.pdf

Checklists:ISO 14971 Checklist Report on MANUFACTURER.pdf

Checklists:ISO 14971 Checklist Report on USER.pdf

Checklists:ISO 14971 Checklist Report on PROCESS.pdf

Checklists:ISO 14971 Checklist Report on ORGANIZATION.pdf

Checklists:ISO 14971 Checklist Report on DEVICE.pdf



STEP 1 Get your bearings:


STEP 1 Get your bearings:ISO 14971 Self-Assessment Pre-Filled EXAMPLE.xlsx

STEP 1 Get your bearings:ISO_14971_Quick_Exploratory_Self-Assessment_Guide.pdf





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


STEP 2 Set concrete goals tasks dates and numbers you can track:ISO 14971 Self-Assessment.xlsx

STEP 2 Set concrete goals tasks dates and numbers you can track:ISO_14971.pdf

..and the Project Management resources in 'STEP 3: Implement, Track, follow up and revise strategy' as described above.

 

 

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