by ptlsolut | Oct 11, 2023 | FDA Programs
But fast-track designation still may not be the best path to market. On September 14, 2023, FDA watchers were scrambling to parse new guidance issued by the FDA regarding their Breakthrough Devices Program. The exciting news: there are now even more ways to qualify as...
by ptlsolut | Aug 22, 2022 | Quality Management Systems
In our first article discussing timing in the context of designing a new medical device, we discussed the technical feasibility process (TFP), or the stage in which medical device concepts are designed prior to the initiation of the formal design control process. The...
by ptlsolut | Jun 13, 2022 | Quality Management Systems
In our first article discussing “timing” in the context of designing a new medical device, we discussed the technical feasibility process (TFP), or the stage in which medical device concepts are designed and matured prior to the initiation of the formal design control...
by ptlsolut | Mar 14, 2022 | Product Development
The technical feasibility process (TFP), or the stage in which medical device conceptual designs are developed prior to initiating the formal design control process, has long been a subject seldom discussed. Yet, it is a critical stage of the overall development...
by ptlsolut | Jan 31, 2022 | FDA Compliance
Warning letters issued by FDA to medical device manufacturers are a significant concern that can mean challenging times ahead for the manufacturer. Warning letters certainly have a negative stigma attached, and for good reason, as they are quite often a sign of...
