Medical Device Reporting Toolkit

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


STEP 1: Get your bearings

Start with...

  • The latest quick edition of the Medical device reporting 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 973 new and updated case-based questions, organized into seven core areas of process design, this Self-Assessment will help you identify areas in which Medical device reporting improvements can be made.

Examples; 10 of the 973 standard requirements:

  1. How would you assess the education and experience of recent job applicants for open positions in your organization, relative to the ideal requirements for education and experience for the position?

  2. How will local communities know where to locate police and fire stations, health clinics and any number of other facilities when block level data no longer will be available?

  3. Are there lessons from the progress of cybersecurity in the medical device sector that can benefit other parts of the health care sector, as well as the sector as a whole?

  4. How important is it for the system of redress in your country to be based on the ability of the patient to prove an error was made by one or more healthcare professionals?

  5. What is the process / procedure for this consideration and how will both the developer/manufacturer and your organization be held to the conclusions drawn from it?

  6. Where a product is certified for different attributes by different certification or field evaluation agencies, which organization(s) is responsible for reporting?

  7. What do you think should be the essential components of a patient safety strategy in your country or the patient safety elements of a healthcare quality strategy?

  8. Does the event represents a death or unanticipated serious deterioration in state of health where a link has been established between the device and the event?

  9. Did the learning experience and the instructional methods used result in individual behavioral or performance change, that is, the intended learning outcomes?

  10. Are the data being used to evaluate a single technology against one standard of care, or are they intended to be used to evaluate multiple technologies?


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 Medical device reporting book in PDF containing 973 requirements, which criteria correspond to the criteria in...

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

  • 62 step-by-step Medical device reporting Project Management Form Templates covering over 1500 Medical device reporting project requirements and success criteria:

Examples; 10 of the check box criteria:

  1. Activity Duration Estimates: Is corrective action taken to bring Medical device reporting project performance into line with the Medical device reporting project plan?

  2. WBS Dictionary: Do work packages reflect the actual way in which the work will be done and are they meaningful products or management-oriented subdivisions of a higher level element of work?

  3. Procurement Audit: Is it on a regular basis examined whether it is possible to enter into public private partnerships with private suppliers?

  4. Executing Process Group: What were things that you did very well and want to do the same again on the next Medical device reporting project?

  5. Procurement Audit: When competitive dialogue was used, did the contracting authority provide sufficient justification for the use of this procedure and was the contract actually particularly complex?

  6. Stakeholder Management Plan: Is an industry recognized mechanized support tool(s) being used for Medical device reporting project scheduling & tracking?

  7. Cost Management Plan: Is current scope of the Medical device reporting project substantially different than that originally defined?

  8. WBS Dictionary: What should you drop in order to add something new?

  9. Activity Cost Estimates: What cost data should be used to estimate costs during the 2-year follow-up period?

  10. Cost Management Plan: Have external dependencies been captured in the schedule?

 
Step-by-step and complete Medical device reporting Project Management Forms and Templates including check box criteria and templates.

1.0 Initiating Process Group:

  • 1.1 Medical device reporting project Charter
  • 1.2 Stakeholder Register
  • 1.3 Stakeholder Analysis Matrix


2.0 Planning Process Group:

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

In using the Toolkit you will be better able to:

  • Diagnose Medical device reporting 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 Medical device reporting 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 Medical device reporting investments work better.

This Medical device reporting 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.