Design Control Toolkit

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Create high quality deliverables using appropriate business and technical language, especially developing and reviewing audit programs or testing steps, adapting an audit program to suit a clients specific environment, and/or Design Controls evaluations and testing Work Plans.

More Uses of the Design Control Toolkit:

  • Secure that your organization develops and applies computer aided design (CAD) Software Engineering methods, theories and research techniques in the investigation and solution of technical problems.

  • Formulate the medium term regulatory policy into a regulatory strategic plan, while also being involved in developing, modifying and executing organization regulatory strategies and policies that affect immediate operations.

  • Establish that your business translates customer and business strategies into engineering design concepts and drive efficient Product Development with modern Design Control processes.

  • Support post market surveillance processes through the analysis of field performance, identification of trends and risks, and actions to eliminate or mitigate adverse post market issues.

  • Ensure you engineer; build relationships with technical and compliance teams to deliver Privacy by Design Controls that are incorporated into Security Architecture, infrastructure, and code.

  • Provide Quality Assurance expertise and guidance for new Product Development/Design Control, Risk Management, manufacturing, supplier qualification, material qualification, and Product Quality.

  • Ensure you persuade; lead system level root cause investigations, coordinate design improvements with development partners, Strategic Planning and execution of design changes and improvements.

  • Perform product definition, System Architecture, requirements writing, Requirements Management, Requirements Analysis, Risk Analysis, Hazard Analysis, product test and evaluation, System V and V, and/or Design Control documentation.

  • Execute packaging development activities in alignment with the elements of Design Controls, and ensure that all packaging materials/systems comply with departmental and applicable Regulatory Requirements.

  • Generate test protocols, manage test execution, investigate test issues, analyze data, and create reports for design verification and validation testing.

  • Provide technical guidance and support based on overall project plans with the development of products in compliance with Design Controls, processes in compliance with Good Manufacturing Practices (cGMP).

  • Be certain that your operation supports design assurance Quality Engineers with product improvement through implementation of Quality Management policies, procedures, specifications, Test Methods and measurement systems.

  • Support new product introduction projects through development and execution of Process Validation and verification Test Plans, protocols, and reports.

  • Collaborate closely with cross functional team members mechanical, electronic, software, clinical, regulatory, and Quality Engineering disciplines to design iterations to quickly and effectively develop effective User Interfaces.

  • Manage work with Systems Engineering and other cross disciplinary engineering functions to support development of Test Cases and protocols for design verification.

  • Evaluate the design feasibility of new product ideas and use Design Control processes to develop new product designs from concept to commercialization.

  • Manage: creative and innovative thinking to resolve issues and overcome obstacles, using sound judgment and structured methods to effectively analyze options, risks and implications.

  • Secure that your team contributes to defining the direction for new products, processes, standards, or operational plans based on Business Strategy with a significant impact on work group results.

  • Direct: work is expected to result in significant contributions to the development of new or refined equipment, materials, processes, products, and/or methods.

  • Make sure that your team adheres to stated Policies and Procedures relating to Health And Safety, and Quality Management in support of your organizations SOPs and best practices.

  • Confirm your planning ensures compliance with quality and Regulatory Requirements by applying Design Control processes as Risk Management, Configuration Management, Requirements Management and verification testing.

  • Determine feasibility of designing equipment or modifying existing equipment considering costs, time limitations, organization planning, and other technical and economic factors.

  • Manage: complete planning and execution of Design Controls, Risk Management, test method development and validation, design verification/validation for new and existing products.

  • Provide guidance and decisions on Product Development activities to ensure continued compliance with internal procedures, and applicable regulatory and international standards.

  • Secure that your business represents organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels.

  • Standardize: actively engage and support the device development engineering core team to ensure the combination product and engineering execution against the established requirements.

  • Provide Technical Support based on overall project plans with the development of products in compliance with Design Controls and processes in compliance with Good Manufacturing Practices (GMP).

  • Supervise: confident when interacting with various levels of management, stays focused and on point, and can raise problems or challenges in a productive manner.

  • Perform requirements Engineering Management, ensuring requirements are structured, organized, maintained, and communicated across multi disciplined and multi site teams.

  • Methodize: actively lead the interactions with the contract manufacturer and suppliers as IT related to quality and provide support in the resolution of quality problems.


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

STEP 1: Get your bearings

Start with...

  • The latest quick edition of the Design Control 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 999 new and updated case-based questions, organized into seven core areas of Process Design, this Self-Assessment will help you identify areas in which Design Control improvements can be made.

Examples; 10 of the 999 standard requirements:

  1. What are hidden Design Control quality costs?

  2. Who uses your product in ways you never expected?

  3. Who is on the team?

  4. Is pre-qualification of suppliers carried out?

  5. How will your organization measure success?

  6. What is the scope of the Design Control effort?

  7. Do you combine technical expertise with business knowledge and Design Control Key topics include lifecycles, development approaches, requirements and how to make your organization case?

  8. How do you govern and fulfill your societal responsibilities?

  9. When you map the key players in your own work and the types/domains of relationships with them, which relationships do you find easy and which challenging, and why?

  10. What is the scope of the Design Control work?

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 Design Control book in PDF containing 994 requirements, which criteria correspond to the criteria in...

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

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

Examples; 10 of the check box criteria:

  1. Cost Management Plan: Eac -estimate at completion, what is the total job expected to cost?

  2. Activity Cost Estimates: In which phase of the Acquisition Process cycle does source qualifications reside?

  3. Project Scope Statement: Will all Design Control project issues be unconditionally tracked through the Issue Resolution process?

  4. Closing Process Group: Did the Design Control project team have enough people to execute the Design Control project plan?

  5. Source Selection Criteria: What are the guidelines regarding award without considerations?

  6. Scope Management Plan: Are Corrective Actions taken when actual results are substantially different from detailed Design Control project plan (variances)?

  7. Initiating Process Group: During which stage of Risk planning are risks prioritized based on probability and impact?

  8. Cost Management Plan: Is your organization certified as a supplier, wholesaler, regular dealer, or manufacturer of corresponding products/supplies?

  9. Procurement Audit: Was a formal review of tenders received undertaken?

  10. Activity Cost Estimates: What procedures are put in place regarding bidding and cost comparisons, if any?

Step-by-step and complete Design Control 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 Design Control 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 Design Control project or Phase Close-Out
  • 5.4 Lessons Learned



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

In using the Toolkit you will be better able to:

  • Diagnose Design Control 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 Design Control 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 Design Control investments work better.

This Design Control 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.