Medical Device Design Traceability Matrix Template

Once you ve defined and gathered your documents you re ready to make your traceability matrix template.

Medical device design traceability matrix template.

In this third video in the medical device plm series we show you how you can use minervas medical device plm solution to get a traceability matrix that will. Other requirements fda guidance documents. Laser marking on medical equipment enables you to get permanent marking resistant to sterilization processes. This traceability system is able to engrave logos datamatrix codes serial numbers or any other information required to identify a medical device.

Design validation on the other hand ensures that the device meets user needs and intended uses and will therefore become a viable product in the marketplace. Process validation uses objective evidence to make sure a process consistently produces the same result. For a basic traceability matrix your columns will be. The design requirements traceability matrix drtm is a combination of two documents that have been used for the past two decades by medical device manufacturers.

Medical device design validation. Confirmation of the device s design. Design verification is all about confirming by objective evidence that your device s design output meets its design input so that a manufacturer can say i made the product correctly in most cases comparing outputs to inputs shows that the device. Design control guidance for medical device manufacturers 1997.

1 the design requirements matrix or iovv i e inputs outputs verification and validation and 2 the risk traceability matrix. Manufacturers in the medical market and healthcare institutions are regulated by very strict. Create a traceability matrix template in excel. Risk analysis hazard traceability matrix template free 0 00 this is a downloadable template which applies to medical devices including in vitro diagnostic medical devices and active implantable medical devices.

You ll need to add a column for each of your artifacts. Is there a documented traceability analysis or matrix linking product design requirements design specifications risks and controls and tests.