Description

Determine the sweet spot for cycle efficiency

What information should be provided regarding the material composition of the medical device?

Is the medical device intended to contact the patient or other persons?

Does the device have the same chemical composition?

Why do you need to do medical device risk management?

Is the material same as in commercially available device?

...Find the answers to these, and more, questions with this ISO 10993 Toolkit:

Know if you are looking at a comprehensive and high-quality life cycle assessment study.
Decide on extracting media and conditions.
Keep up to date with the changes in industry.
Really find out what is needed.
Establish a sampling plan for in process testing and finished product release.
Obtain a snug marginal fit.
Address toxicity for Nano Materials.
Evaluate risks arising from risk control measures themselves.
Write instructions that minimize user error.

HOW THIS TOOLKIT WORKS:

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 1000 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 1000 standard requirements:

When an issued report needs to be changed, amended or re issued, is any change of information clearly identified and, where appropriate, the reason for the change included in the report?
Are precautions taken to avoid deterioration, contamination, loss or damage to the item during handling, transporting, storing/waiting, and preparation for, testing or calibration?
Does the laboratory management provide evidence of commitment to the development and implementation of the management system and to continually improving its effectiveness?
Does the laboratory implement the controls needed for the identification, storage, protection, back up, archive, retrieval, retention time, and disposal of its records?
Are the performance characteristics of validated methods as assessed for the intended use, relevant to the customers needs and consistent with specified requirements?
How exactly does an engineer contribute to medical device design, manufacturing, testing and validation, numerical simulation, or monitoring of product performance?
When intermediate checks are necessary to maintain confidence in the performance of the equipment, are checks shall be carried out according to a procedure?
Do the technical records include the date and the identity of personnel responsible for each laboratory activity and for checking data and results?
Does the laboratory take responsibility for all the information provided in the report, except when information is provided by the customer?
Is it isolated to prevent its use or clearly labelled or marked as being out of service until it has been verified to perform correctly?

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 1000 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:

Schedule Management Plan: Do ISO 10993 project managers participating in the ISO 10993 project know the ISO 10993 projects true status first hand?
Lessons Learned: What was helpful to know when planning the deployment?
Quality Audit: Is your organizations resource allocation system properly aligned with its collection of intentions?
Activity List: Can you determine the activity that must finish, before this activity can start?
Procurement Audit: Is there a policy covering the relationship of other departments with vendors?
WBS Dictionary: Is budgeted cost for work performed calculated in a manner consistent with the way work is planned?
Schedule Management Plan: Are any non-compliance issues that exist due to your organizations practices communicated to your organization?
Lessons Learned: Was any formal risk assessment carried out at the start of the ISO 10993 project, and was this followed up during the ISO 10993 project?
Schedule Management Plan: Are procurement deliverables arriving on time and to specification?
Procurement Audit: If the expert was allowed to submit a tender, was all the relevant information the expert had gained from his earlier involvement made available to the other bidders?

Step-by-step and complete ISO 10993 Project Management Forms and Templates including check box criteria and templates.

1.0 Initiating Process Group:

1.1 ISO 10993 project Charter
1.2 Stakeholder Register
1.3 Stakeholder Analysis Matrix

2.0 Planning Process Group:

2.1 ISO 10993 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 10993 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 10993 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 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

Results

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.

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Checklists:

Checklists:ISO 10993 Checklist Report on RISK.pdf

Checklists:ISO 10993 Checklist Report on PROCESS.pdf

Checklists:ISO 10993 Checklist Report on LABORATORY.pdf

Checklists:ISO 10993 Checklist Report on INFORMATION.pdf

Checklists:ISO 10993 Checklist Report on PRODUCT.pdf

Checklists:ISO 10993 Checklist Report on ORGANIZATION.pdf

Checklists:ISO 10993 Checklist Report on TESTING.pdf

Checklists:ISO 10993 Checklist Report on DEVICE.pdf

STEP 1 Get your bearings:

STEP 1 Get your bearings:ISO_10993_Quick_Exploratory_Self-Assessment_Guide.pdf

STEP 1 Get your bearings:ISO 10993 Self-Assessment Pre-Filled EXAMPLE.xlsx

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_10993.pdf

STEP 2 Set concrete goals tasks dates and numbers you can track:ISO 10993 Self-Assessment.xlsx

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

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These skills will enrich every part of your life.

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ISO 10993 Toolkit