Showing posts tagged with: Traceability Matrix
A new Traceability Matrix so powerful, it becomes the products dashboard
TM is now more effective and useful feature that serves as a dashboard for product development leading to submission.
You build your Traceability Matrix as you develop your product...
Key functions of qmsWrapper Traceability Matrix:
track and show the relationships and connections between requirements
end to end traceability
design controls, by column
tracking number automatically assigned and inherited
export into a print-ready...
Wrap Jira in QMS
27th November 2019
Toronto, CA - QmsWrapper, a world-famous QMS System that helps Meddev startups and small businesses achieve and manage ISO 13485:2016 and 21 CFR 820, announces that the future is now available with the latest release where vision meets functionality.
Vs6.0 will radically change the way you look at QMS. It moves away from being...
How CAPA should be verified?
“Efficiency without Effectiveness misses the Purpose
Effectiveness without Efficiency misses all the Profit
Effectiveness with Efficiency brings Performance.”
― Martin U. Ugwu
Verifying the effectiveness of corrective and preventive actions (CAPAs) closes the loop between identifying a problem and completing the actions to solve it.
Reminder: The main purpose of corrective and preventive actions (CAPA) is to improve the organization processes...
Weekly Cup of Joe 30# – DHFs & CE Technicals with Traceability Matrix
An effective traceability process is an essential requirement when developing medical device software and achieving regulatory compliance.
How to create a Traceability Matrix?
Traceability Matrix can be very difficult to create. It can take months to put together manually, especially without a proper tool. Creating and maintaining a TM can be time-consuming and difficult, not to mention all...
How to stay on top of your product development and easily organize your FDA and CE submission
Traceability is required by regulations.
Traceability Matrix Updated 2019,
For FDA, 510(k), DeNovo or PMA, traceability is required as part of your Design History File (DHF). Soup to nuts, they expect you to demonstrate how it is all connected, where and how requirements were met.
For the CE mark, the requirements are similar, if not the same!
Failure to...