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 13 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:
Merge ISO 10993-19 engagements and define ISO 10993-19 competency-based leadership.
– How do you incorporate cycle time, productivity, cost control, and other efficiency and effectiveness factors into these ISO 10993-19 processes?
– Who are the people involved in developing and implementing ISO 10993-19?
– How can you measure ISO 10993-19 in a systematic way?
ISO 10993 Critical Criteria:
Do a round table on ISO 10993 strategies and get out your magnifying glass.
– What is the total cost related to deploying ISO 10993-19, including any consulting or professional services?
– What new services of functionality will be implemented next with ISO 10993-19 ?
– What will drive ISO 10993-19 change?
Biocompatibility Critical Criteria:
Chart Biocompatibility risks and create Biocompatibility explanations for all managers.
– Consider your own ISO 10993-19 project. what types of organizational problems do you think might be causing or affecting your problem, based on the work done so far?
– Do those selected for the ISO 10993-19 team have a good general understanding of what ISO 10993-19 is all about?
– In a project to restructure ISO 10993-19 outcomes, which stakeholders would you involve?
Medical devices Critical Criteria:
Bootstrap Medical devices issues and interpret which customers can’t participate in Medical devices because they lack skills.
– What tools and technologies are needed for a custom ISO 10993-19 project?
– Is there any existing ISO 10993-19 governance structure?
– What about ISO 10993-19 Analysis of results?
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 | 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:
Prüfung von Medizinprodukten nach ISO 10993 – laus.deTranslate this page
PN-EN ISO 10993-1:2010 – wersja polska – Sklep PKNTranslate this page
AENOR: Norma UNE-EN ISO 10993-1:2010
Biocompatibility External links:
Biocompatibility Testing & ISO 10993 Tests – Pacific Biolabs
Toxicology / Biocompatibility – Geneva Labs
Sample Requirements for Biocompatibility Testing
Medical devices External links:
DMG ITALIA – Medical Devices – Nutritional Supplements
Medical Devices | Consumer Goods and Retail | SGS