Risk management tools

[navdeep]

Hi, I am working for a medical device start up company and need some help with tools for managing requirements and traceability. Can anyone recommend me any good tools? Thanks Navdeep Kaur Cheema

 

[Tidge]

If the company is not particularly mature, I recommend using simply tools like paper/spreadsheets for traceability initially.

My attitude comes from a mental model of not giving novices advanced mills and jigs... I believe folks need to understand the purpose of the tools and nuance about the types of things required by and possible through traceability before they dive right into a tool... otherwise they end up learning more about the tool than the quality of the work done with the tool.

 

[Enternationalist]

Seconding this. It's a start-up. Throw it into an Excel sheet.

 

[QuinnM]

If you are at the point of developing design documentation, then the traceability should be imbedded into the documentation. In the short term, as noted above, an Excel sheet will work.

 

[Sidney Vianna]

Hi, I am working for a medical device start up company and need some help with tools for managing requirements and traceability. Can anyone recommend me any good tools? Thanks Navdeep Kaur Cheema

Soon you should be able to purchase a new ISO standard that will help you in this endeavor.

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[Bev D]

Be afraid. Be very afraid.

 

[navdeep]

Thank you everyone for the response.

 

[Hi_Its_Matt]

The company I work for uses Matrix Requirements, and we have been rather satisfied with it. It isn't particularly pretty, but its quite configurable. I have found that I prefer this compared to other much more rigid eQMS/design control software options you will find. I believe it is relatively inexpensive though, but everything costs more than a simple Excel spreadsheet.