What is involved in ISO 10993-19
Find out what the related areas are that ISO 10993-19 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 10993-19 thinking-frame.
How far is your company on its ISO 10993-19 journey?
Take this short survey to gauge your organization’s progress toward ISO 10993-19 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 10993-19 related domains to cover and 11 essential critical questions to check off in that domain.
The following domains are covered:
ISO 10993-19, ISO 10993, Biocompatibility, Medical devices:
ISO 10993-19 Critical Criteria:
Pay attention to ISO 10993-19 governance and describe the risks of ISO 10993-19 sustainability.
– What is the total cost related to deploying ISO 10993-19, including any consulting or professional services?
– How will you measure your ISO 10993-19 effectiveness?
– How do we keep improving ISO 10993-19?
ISO 10993 Critical Criteria:
Distinguish ISO 10993 tactics and define what our big hairy audacious ISO 10993 goal is.
– What are the record-keeping requirements of ISO 10993-19 activities?
– Is there any existing ISO 10993-19 governance structure?
– Are there ISO 10993-19 Models?
Biocompatibility Critical Criteria:
Meet over Biocompatibility visions and correct Biocompatibility management by competencies.
– How do senior leaders actions reflect a commitment to the organizations ISO 10993-19 values?
– What are the Key enablers to make this ISO 10993-19 move?
Medical devices Critical Criteria:
Have a meeting on Medical devices governance and correct Medical devices management by competencies.
– Who sets the ISO 10993-19 standards?
– What is Effective ISO 10993-19?
– Is ISO 10993-19 Required?
This quick readiness checklist is a selected resource to help you move forward. Learn more about how to achieve comprehensive insights with the ISO 10993-19 Self Assessment:
Author: Gerard Blokdijk
CEO at The Art of Service | http://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:
A Practical Guide to ISO 10993-10: Irritation | MDDI Online
MassMEDIC Webinar: ISO 10993 Update: Understanding …
Biocompatibility Testing & ISO 10993 Tests – Pacific Biolabs
Biocompatibility External links:
Contact Lens Biocompatibility Analysis – LSU Eye Center
Biocompatibility Testing Services | NAMSA
Medical devices External links:
Project and Risk Management for medical devices | Gantus …