If you have a fairly typical MDSW app that takes in some data, does a calculation and displays an answer or report (i.e. structurally it's very simple) but it includes dozens, maybe hundreds of small "SOUP" items like standard windows components, dlls etc. It doesn't seem reasonable/possible to get that into the architecture, one by one in a diagram, and does it make sense to include as a list (client is exporting a document with a list of all SOUP items, with version numbers and website... Read more ..read more

I work for a pharma that uses REES Environmental Monitoring System to monitor the entire facility. REES monitors the temperature, humidity, and differential pressure all across the facility. I have worked with this software at my previous job as well and it still has the same issues such as Inputs dropping, losing connectivity, battery drainage... Has anyone used this software and was able to "tame the beast?" Or does anyone deal with other issues that you can make me aware of? I am trying... Read more ..read more

Our pipe sizing operation (Tube end forming using I/O MACHINE) and then flange and another pipe gets welded to this sized pipe. After all this operations, pipe OD at inlet should maintain a tolerance range of 53.7mm to 54.3mm. Following a capability study, we determined that our Cp value stands at 1.03, with a sample mean of 53.9921mm. The customer has requested shifting the sample mean to 53.85mm. Considering the process variation and capability, we need to clarify the feasibility of this... Read more ..read more

Folks, We have a Contract Manufacturer who performs IQC/ Acceptance Activities for the Manufacturer. How do I write the procedure that is compliant to 820 subpart H and can be deployed as a list of requirement that the Contract Manufacturer should meet. It is not prescriptive, but is more high level and is written in a form of a Requirement ..read more

Hi, I have a problem with the 2kV line to Gnd passing though my power supply and disrupting the operation of a surgical generator. The surge seems relatively easy to supress with varistors, or a combination of them with a gas tube. However there is, I think, a requirement with withstand an electrical stress test of kV from the Lines to earth. The protection will obviously conduct and the test will fail. This is a Class I device with an earth terminal. Is there any way around this dilemma... Read more ..read more

With the upcoming revision to the EU Product Liability Directive, which I believe is likely to be approved in the next couple of months, I was wondering if there would be knock-on impacts to what needs to be considered through medical device risk management activities? In the revision there is an expanded definition of 'damage' to include 'medically recognised harm to psychological health'. In light of that should product risk be considering this as an additional set of potential harms? Or... Read more ..read more

Is there a rule of thumb of how many steps a process should not exceed? I know its dependent on the process, but ideally is 20 steps, for example, far too many? We are running into issues where process maps are becoming a nightmare, and I am thinking that we need to seriously rethink our process creation and approach. Thanks ..read more

Hi all, Working on a medical device and planning to cover a mesh speaker hole in the device's housing with the product label. We would like to use perforated design like this on the label over to cover the mesh speaker. Here is the design we want to include on the label: imghippo. com /i/vYqgk1714503518.png It is my understanding that the final rule on symbols is that proprietary symbols cannot be used. However, this is not a "symbol" that will be used to convey information, rather, it... Read more ..read more

Hello all and TIA! I am VERY new to GAGEpack. I am trying to create custom filters, for example all gages at X location., However, only 8 fields are displayed in the filter drop down. The user guide is clear to use the drop down to select the field but offers no trouble shooting if fields don't exist. Thank you! Mike ..read more

Hello. The organization I work for is considering taking on an RF microneedling device. I know as far as FDA clearance, the product does not require FCC certification, but to import and market the device in the US, would an RF microneedling laser require FCC certification? I don't see any of the predicate devices with FCC certification, but it appears from reading the testing and compliance requirements, that such a device would be an intentional radiator and therefore, would require... Read more ..read more