Medical Device Design Traceability Matrix Template

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. Is there a documented traceability analysis or matrix linking product design requirements design specifications risks and controls and tests. Design control guidance for medical device manufacturers 1997.

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Risk analysis hazard traceability matrix template free 0 00 design and development plan template medical device per iso 13485 and 21 cfr 820 free 0 00 checklist iso 14971 2007 to iso 14971 2019 free 0 00 status report template full free 0 00 design review record template free 0 00.

Medical device design traceability matrix template. 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. For a basic traceability matrix your columns will be. 1 the design requirements matrix or iovv i e inputs outputs verification and validation and 2 the risk traceability matrix. This traceability system is able to engrave logos datamatrix codes serial numbers or any other information required to identify a medical device.

Process validation uses objective evidence to make sure a process consistently produces the same result. There are two common types of validation. You ll need to add a column for each of your artifacts. Manufacturers in the medical market and healthcare institutions are regulated by very strict.

Other requirements fda guidance documents. Traceability of medical devices. Medical device design validation. 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.

Laser marking on medical equipment enables you to get permanent marking resistant to sterilization processes. Once you ve defined and gathered your documents you re ready to make your traceability matrix template. Create a traceability matrix template in excel. 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.

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. Confirmation of the device s design.