ISO 10993 A Complete Guide - 2021 Edition

Are there reactive functional groups that may form covalent binding with protein?

carbon dioxide emissions from burning biomass/biofuels) relevant to your organization?

Did the physical presence of the test material itself influence the test findings?

Does the device provide appropriate performance characteristics over the device use life?

What attributes of the raw materials are important to the final biological product?

What information should be provided regarding the sterilization of the medical device?

Which biocompatibility tests are necessary on semi-finished products for your application?

Who do you think is likely to be most similar to you, biologically or genetically?

Why build more concrete storage facilities when the space is available nearby?

Will the dye be depleted if the AMG Antimicrobial Gloves are continually exposed to light?

This ISO 10993 Guide is unlike books you're used to. If you're looking for a textbook, this might not be for you. This book and its included digital components is for you who understands the importance of asking great questions. This gives you the questions to uncover the ISO 10993 challenges you're facing and generate better solutions to solve those problems.

Defining, designing, creating, and implementing a process to solve a challenge or meet an objective is the most valuable role… In EVERY group, company, organization and department.

Unless you're talking a one-time, single-use project, there should be a process. That process 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 Self-Assessment 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.

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INCLUDES all the tools you need to an in-depth ISO 10993 Self-Assessment. Featuring new and updated case-based questions, organized into seven core levels of ISO 10993 maturity, this Self-Assessment will help you identify areas in which ISO 10993 improvements can be made.

In using the questions 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.

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Using the Self-Assessment tool gives you the ISO 10993 Scorecard, enabling you to develop a clear picture of which ISO 10993 areas need attention.

Your purchase includes access to the ISO 10993 self-assessment digital components which gives you your dynamically prioritized projects-ready tool that enables you to define, show and lead your organization exactly with what's important.

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전자책 : 2020년 11월 27일