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Back to looslib and Matt's suggestion about referencing the model; this can certainly be done per 14.41, but we make class III orthopedic implants. Class I devices do not have to follow design controls as layed out in 21 CFR, section 801. Matt, if you produce Class II or III devices, I'd like...

Also, you are right David. The standard is rather robust, but SW2005 does not appear to be able accommodate the requirements. Does SW2006 or SW2007? Don't ask why we are still on 2005; there's not enough room here... Phil

I've obtained a copy of the ANSI Y 14.41 and believe that is how we will proceed. Thanks for the encouragment Matt. Hearing from the industry helps immensely. Phil

Thanks Guys. I believe we will pursue the Model Based Definition. However, this is a medical device and design controls may dictate more robust documentation. Also, the twist I described was not created with a helix. It's less pronounced. Sort of like grabbing a piece of licorice, twisting 10...

We have a part that is very complex. Our vendors can make if from a parasolid, but we have yet defined it on a drawing. The part has three features; one end is slotted and flat, the other round and tapered. In between is a complex twist extrusion. Overall length is about 2 inches. How can we...

We are designing a custom drill for orthopedic use and need to dimension the flutes and the tip including the web, land, chisel edge, etc. ASME B94.11M-1993 does not show helix angles, web thickness dimensions and the like; nor does the Machinery's Handbook. Does anyone have an example of an...

Thanks guys. It'll take a couple of days to break from the daily routine and dig back into PDMW. I'll post my experience in the coming days. Pberg

Would setting up three lifecycles allow for three differing revision formats? i.e. Lifecycle: Prototype Rev:01-99 Lifecycle: Release Rev: A-Z Lifecycle: Production Rev: PA-PA thanks for the response, PBerg

Our company has chosen to use three revision levels; Prototype (01-99), Release (A-Z) and Production Release (PA-PZ). PDMWorks allows Primary, Secondary and Tertiary revision schemes. I cannot get the three to work. I check-In a document at 01 and cannot get it to revise up to A or PA. Anyone...