Medical Devices and Drugs RIM Toolkit

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


STEP 1: Get your bearings

Start with...

  • The latest quick edition of the Medical Devices and Drugs RIM 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 996 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 Devices and Drugs RIM improvements can be made.

Examples; 10 of the 996 standard requirements:

  1. Are you seeing and understanding the right areas of your organization to detect the issues and corrections that will make your devices safer and prevent defects from getting on the market?

  2. What evidence is available that your organization evaluates and selects suppliers based on ability to supply product in accordance with your organizations requirements?

  3. Does the products required labeling provide the necessary information to use the product safely and effectively under the conditions suggested in the communication?

  4. Why do projects that simply rely on cutting and pasting the regulations into a clients pharmaceutical quality system rarely provide perpetual compliance to cGMP?

  5. Has the establishment of a procedure on requirements and responsibilities, record maintenance and information exchange with external parties been implemented?

  6. How do you conduct your review of the system to ensure that all areas of the system are functioning and improvements are happening where planned and expected?

  7. What is regulatory theory and how does it influence medical device regulation to support optimal regulation for patient safety and industry innovation?

  8. Has the requirement that feedback for risk management processes should be used to monitor and maintain product requirements been taken into account?

  9. Has the requirement for a documented process for product identification and identification and product status during production been implemented?

  10. Has your organization defined a management representative with executive responsibility for implementing and reporting Quality Management System?


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 Devices and Drugs RIM book in PDF containing 996 requirements, which criteria correspond to the criteria in...

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

  • 62 step-by-step Medical Devices and Drugs RIM Project Management Form Templates covering over 1500 Medical Devices and Drugs RIM project requirements and success criteria:

Examples; 10 of the check box criteria:

  1. Stakeholder Management Plan: Has a quality assurance plan been developed for the Medical Devices and Drugs RIM project?

  2. Procurement Management Plan: Have activity relationships and interdependencies within tasks been adequately identified?

  3. Issue Log: Who have you worked with in past, similar initiatives?

  4. Risk Management Plan: Have customers been involved fully in the definition of requirements?

  5. Variance Analysis: How do you identify and isolate causes of favorable and unfavorable cost and schedule variances?

  6. Change Request: Have all related configuration items been properly updated?

  7. Procurement Audit: Are there reasonable procedures to identify possible sources of supply?

  8. Procurement Audit: Are there procedures to ensure that changes to purchase orders will be updated on the computer files?

  9. Stakeholder Management Plan: Does the role of the Medical Devices and Drugs RIM project Team cease upon the delivery of the Medical Devices and Drugs RIM projects outputs?

  10. Risk Management Plan: How will the Medical Devices and Drugs RIM project know if your organizations risk response actions were effective?

 
Step-by-step and complete Medical Devices and Drugs RIM Project Management Forms and Templates including check box criteria and templates.

1.0 Initiating Process Group:

  • 1.1 Medical Devices and Drugs RIM project Charter
  • 1.2 Stakeholder Register
  • 1.3 Stakeholder Analysis Matrix


2.0 Planning Process Group:

  • 2.1 Medical Devices and Drugs RIM 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 Devices and Drugs RIM 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 Devices and Drugs RIM 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 Devices and Drugs RIM 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 Devices and Drugs RIM 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 Devices and Drugs RIM project with this in-depth Medical Devices and Drugs RIM Toolkit.

In using the Toolkit you will be better able to:

  • Diagnose Medical Devices and Drugs RIM 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 Devices and Drugs RIM 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 Devices and Drugs RIM investments work better.

This Medical Devices and Drugs RIM 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.