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:

Graph ISO 10993-19 engagements and get the big picture.

– What will be the consequences to the business (financial, reputation etc) if ISO 10993-19 does not go ahead or fails to deliver the objectives?

– What are the record-keeping requirements of ISO 10993-19 activities?

– How do we go about Comparing ISO 10993-19 approaches/solutions?

ISO 10993 Critical Criteria:

Substantiate ISO 10993 engagements and report on developing an effective ISO 10993 strategy.

– Is ISO 10993-19 dependent on the successful delivery of a current project?

– What are our ISO 10993-19 Processes?

Biocompatibility Critical Criteria:

Chat re Biocompatibility results and correct Biocompatibility management by competencies.

– 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?

– How do mission and objectives affect the ISO 10993-19 processes of our organization?

– What about ISO 10993-19 Analysis of results?

Medical devices Critical Criteria:

Face Medical devices engagements and secure Medical devices creativity.

– Does ISO 10993-19 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?

– What other jobs or tasks affect the performance of the steps in the ISO 10993-19 process?

– What threat is ISO 10993-19 addressing?


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

[email protected]


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.

External links:

To address the criteria in this checklist, these selected resources are provided for sources of further research and information:

ISO 10993-19 External links:

Top 12 ISO 10993-19 Questions to Grow – …

ISO 10993 External links:

A Practical Guide to ISO 10993-5: Cytotoxicity | MDDI Online

A Practical Guide to ISO 10993-10: Irritation | MDDI Online

Biocompatibility External links:

Toxicology & Biocompatibility | Nelson Labs

Biocompatibility Test Services – Nelson Labs

Medical devices External links:

Real Staffing – Pharma, Biotech and Medical Devices jobs

Medical Devices – Food and Drug Administration

Categories: Documents