I work in a matrix organization as a Manufacturing Engineer. I love this organizational style because information travels relatively quickly. Just last week I needed help from Regulatory concerning a project. Many members in Regulatory were out due to the holidays. Because of the matrix-styled structure, I could contact anyone in the Regulatory…[Read more]

Regulation and standards should be abided by regardless of cost. Calibrations/maintenance are costly, but must be done. Safety inspections – also costly but must be done. Subscribing to these databases are simply a necessity just like all the tasks above. Each company (ISO, FDA, USP, etc.) needs to hire regulation specialists to verify that these…[Read more]

AFAP is deemed acceptable when death or serious deterioration of health is unlikely. ALARP is not acceptable with regard to economic consideration. ALARP has more to do with acceptability of the risk. Also ISO 14971 allows risks to be reduced ALARP and the European Directives require all risks to be reduced AFAP without economic…[Read more]

From personal experience, I know that the most difficulty in risk management is the need to state a reason for the result. Filling out the risk management assessment gives results. These results, however, need to be further analyzed.

After doing some perusing online, I found that another mistake in risk management is not creating an avoidance…[Read more]

Legacy devices can be existing devices, modified hardware, and modified software. Legacy medical devices should conform to IEC 62366, a standard that specifies usability requirements for the development of medical devices. Having a summary of known use errors is a good start. A full use-related risk analysis should be performed. Additionally,…[Read more]

Legacy devices can be existing devices, modified hardware, and modified software. Legacy medical devices should conform to IEC 62366, a standard that specifies usability requirements for the development of medical devices. Having a summary of known use errors is a good start. A full use-related risk analysis should be performed. Primary operating…[Read more]

Legacy devices can be existing devices, modified hardware, and modified software. Legacy medical devices should conform to IEC 62366, a standard that specifies usability requirements for the development of medical devices. Having a summary of known use errors is a good start. A full use-related risk analysis should be performed. Primary operating…[Read more]

It’s very difficult to select one part of the DPP over the others. If I were to select one I would have to say scope management plan. This determines how the project scope should be defined, developed and verified. I think a skilled team makes development that much easier. It’s certainly not a requirement. I can’t say the same for the project…[Read more]

It’s very difficult to select one part of the DPP over the others. If I were to select one I would have to say scope management plan. This determines how the project scope should be defined, developed and verified. I think a skilled team makes development that much easier. It’s certainly not a requirement. I can’t say the same for the project…[Read more]

It’s very difficult to select one part of the DPP over the others. I would have to say scope management plan. This determines how the project scope should be defined, developed and verified. I think a skilled team makes development that much easier. It’s certainly not a requirement. I can’t say the same for the project scope. This is the backbone…[Read more]

In design control, there are “checks” to verify that everything (mostly) is accounted for. Companies must question whether the design outputs conform to the design inputs. Was the design done right? Was the right device designed? That being said, it seems like companies get tripped up when design verification and validation are not up to par.…[Read more]