ISO 10993 Toolkit

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Lead with extensive knowledge in the areas of Design Controls, Design Validation and Verification, Risk Management, Process Validation, manufacturing practices/principles, and Statistical Techniques.

More Uses of the ISO 10993 Toolkit:

  • Stay abreast of new or modified standards/regulations relevant to the Quality Systems of client companies.

  • Develop and qualify new test tools and protocols, ensuring that test objectives are effectively incorporated.

  • Apply proactive, systematic Problem Solving methodologies in identifying, prioritizing, communicating and resolving quality issues.

  • Analyze test data for conformance to pre determined acceptance criteria and prepare formal reports and results summaries.

  • Ensure your organization as an integral member of the Quality Team, the Design Quality Assurance engineering provides support for Product Development and pre production manufacturing activities.

  • Establish: work in accordance with and ensure compliance with the Quality System procedures related to areas of responsibility.

  • Be accountable for making a difference in how work and collaborate, constantly nurturing your nimble culture of innovation.

  • Recruit and develop Quality staff to achieve organizational objectives and meet client project needs; Coach and mentor staff.

  • Ensure you succeed; lead in the development of complex technical protocols, reports, and methods in collaboration with intra and inter departmental teams.

  • Develop and implement new and improved quality/compliant pre market engineering methods, techniques and processes.

  • Head: conduct research of regulatory issues and information and dissemination of regulatory information to all levels of your organization.

  • Become capable of working on multiple projects in a deadline driven environment demonstrated skill under pressure.

  • Be accountable for prioritizing project tasks to complete on schedule, maintaining quality of work and providing weekly project Status Reports.

  • Identify procedure and process enhancements for the Continuous Improvement of the Regulatory Affairs team.

  • Be certain that your organization goes beyond existing knowledge base and expands your understanding, methods, and procedures, leaving a base for others to utilize and build upon (trailblazing).

  • Be accountable for learning froM And Adhering to internal quality manual Quality System Procedures, Work Instructions, Forms, etc.

  • Be accountable for maintaining and updating current bio compatibility Quality System Procedures, Work Instructions and Forms.

  • Ensure compliance with applicable you and international Regulatory Requirements and standards pertaining to quality.

  • Be accountable for making a difference in your products, services and offers, never ceasing to fight for groundbreaking solutions in everything you do .

  • Apply technical expertise to solve complex biocompatibility problems as related to the ISO 10993 standards and regulatory authority requirements for product safety.

  • Coordinate and manage product biocompatibility testing of new products per Industry Standards (ISO 10993).

  • Ensure you steer; lead Product Development projects capturing and documenting design inputs and outputs from feasibility through Design Transfer into manufacturing.

  • Evaluate new designs and changes in design per organizational Risk Management practices to ensure effective, safe and compliant devices.


Save time, empower your teams and effectively upgrade your processes with access to this practical ISO 10993 Toolkit and guide. Address common challenges with best-practice templates, step-by-step Work Plans and maturity diagnostics for any ISO 10993 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 10993 specific requirements:

STEP 1: Get your bearings

Start with...

  • The latest quick edition of the ISO 10993 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 ISO 10993 improvements can be made.

Examples; 10 of the 999 standard requirements:

  1. Can the report be read and understood by a third party, does it provide sufficient detail for understanding the data that are available, all assumptions made and all conclusions reached?

  2. Are all incidents that may result in exposure reported to the animal facility supervisor, the Biological Safety Officer, and others designated by your organization?

  3. Are biological safety cabinets located away from doors, windows that can be opened, heavily traveled lab areas, and other potentially disruptive equipment?

  4. 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?

  5. Are standard biocompatibility and IO tests sufficient to determine bioactivity or biocompatibility of Additive Manufacturing materials?

  6. Should all studies using water or soil collected from the environment be considered involving potentially hazardous biological agents?

  7. What equipment and devices are available for clients to prevent harm from falls or to manage clients who are at risk of falling?

  8. Using real world data or other available data, what proportion of clients have been observed to benefit from the device?

  9. Does your project involve human participants, human biological material, or identifiable/potentially identifiable data?

  10. How does the use of mobile devices affect the security risk posture of the healthcare organizations that use devices?

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 10993 book in PDF containing 999 requirements, which criteria correspond to the criteria in...

Your ISO 10993 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 10993 Self-Assessment and Scorecard you will develop a clear picture of which ISO 10993 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 10993 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 10993 projects with the 62 implementation resources:

  • 62 step-by-step ISO 10993 Project Management Form Templates covering over 1500 ISO 10993 project requirements and success criteria:

Examples; 10 of the check box criteria:

  1. Cost Management Plan: Are issues raised, assessed, actioned, and resolved in a timely and efficient manner?

  2. Stakeholder Management Plan: Have the key elements of a coherent ISO 10993 Project Management strategy been established?

  3. Quality Metrics: Did the team meet the ISO 10993 project success criteria documented in the Quality Metrics Matrix?

  4. Executing Process Group: What were things that you did very well and want to do the same again on the next ISO 10993 project?

  5. Cost Baseline: Has the ISO 10993 projected annual cost to operate and maintain the product(s) or service(s) been approved and funded?

  6. Formal Acceptance: Is formal acceptance of the ISO 10993 project product documented and distributed?

  7. Project Performance Report: What degree are the relative importance and priority of the goals clear to all team members?

  8. Scope Management Plan: What should you drop in order to add something new?

  9. Project Charter: Assumptions: what factors, for planning purposes, are you considering to be true?

  10. Human Resource Management Plan: Is there a set of procedures to capture, analyze and act on quality metrics?

Step-by-step and complete ISO 10993 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 ISO 10993 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 10993 project or Phase Close-Out
  • 5.4 Lessons Learned



With this Three Step process you will have all the tools you need for any ISO 10993 project with this in-depth ISO 10993 Toolkit.

In using the Toolkit you will be better able to:

  • Diagnose ISO 10993 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 10993 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 10993 investments work better.

This ISO 10993 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.