What is involved in ISO 10993-12
Find out what the related areas are that ISO 10993-12 connects with, associates with, correlates with or affects, and which require thought, deliberation, analysis, review and discussion. This unique checklist stands out in a sense that it is not per-se designed to give answers, but to engage the reader and lay out a ISO 10993-12 thinking-frame.
How far is your company on its ISO 10993-12 journey?
Take this short survey to gauge your organization’s progress toward ISO 10993-12 leadership. Learn your strongest and weakest areas, and what you can do now to create a strategy that delivers results.
To address the criteria in this checklist for your organization, extensive selected resources are provided for sources of further research and information.
Start the Checklist
Below you will find a quick checklist designed to help you think about which ISO 10993-12 related domains to cover and 10 essential critical questions to check off in that domain.
The following domains are covered:
ISO 10993-12, ISO 10993, Biocompatibility, Medical devices:
ISO 10993-12 Critical Criteria:
Devise ISO 10993-12 risks and find out what it really means.
– How do we manage ISO 10993-12 Knowledge Management (KM)?
– What are internal and external ISO 10993-12 relations?
ISO 10993 Critical Criteria:
Merge ISO 10993 tactics and remodel and develop an effective ISO 10993 strategy.
– Where do ideas that reach policy makers and planners as proposals for ISO 10993-12 strengthening and reform actually originate?
– What role does communication play in the success or failure of a ISO 10993-12 project?
– What are current ISO 10993-12 Paradigms?
Biocompatibility Critical Criteria:
Weigh in on Biocompatibility results and question.
– Will ISO 10993-12 have an impact on current business continuity, disaster recovery processes and/or infrastructure?
– How will you measure your ISO 10993-12 effectiveness?
– Is a ISO 10993-12 Team Work effort in place?
Medical devices Critical Criteria:
Guide Medical devices planning and explore and align the progress in Medical devices.
– Does ISO 10993-12 include applications and information with regulatory compliance significance (or other contractual conditions that must be formally complied with) in a new or unique manner for which no approved security requirements, templates or design models exist?
– Why are ISO 10993-12 skills important?
This quick readiness checklist is a selected resource to help you move forward. Learn more about how to achieve comprehensive insights with the ISO 10993-12 Self Assessment:
Author: Gerard Blokdijk
CEO at The Art of Service | theartofservice.com
Gerard is the CEO at The Art of Service. He has been providing information technology insights, talks, tools and products to organizations in a wide range of industries for over 25 years. Gerard is a widely recognized and respected information expert. Gerard founded The Art of Service consulting business in 2000. Gerard has authored numerous published books to date.
To address the criteria in this checklist, these selected resources are provided for sources of further research and information:
ISO 10993 External links:
Biocompatibility Testing & ISO 10993 Tests – Pacific Biolabs
MassMEDIC Webinar: ISO 10993 Update: Understanding …
A Practical Guide to ISO 10993-5: Cytotoxicity | MDDI Online
Biocompatibility External links:
Biocompatibility Testing Services | NAMSA
Contact Lens Biocompatibility Analysis – LSU Eye Center
Medical devices External links:
Hart Enterprises, Inc. | Custom Medical Devices