Medical Device Document preparation. We have created
hundreds and hundreds of technical/user manuals... in a multitude
of media for a multitude of audiences. Those shown below were
from Raytheon Medical Imaging ....
....circa 1977...talk about experience....
We have created piles and piles of technical documentation including proposals, user manuals, test plans, test procedures, etc. No matter what the subject, no matter what the venue. Circuit theory, source code, user instructions, mechanical disassembly, maintenance, troubleshooting or whatever. We have experience in mentoring your staff to create appropriate documentation OR we can make it under contract for your project.
This photo illustrates one of the three full time professional shifts that worked to document the Hubble Space Telescope
We have created piles and piles of technical documentation including proposals, user manuals, test plans, test procedures, etc. No matter what the subject, no matter what the venue. Circuit theory, source code, user instructions, mechanical disassembly, maintenance, troubleshooting or whatever. We have experience in mentoring your staff to create appropriate documentation OR we can make it under contract for your project.
This photo illustrates one of the three full time professional shifts that worked to document the Hubble Space Telescope
The FDA considers the instructions/labeling EQUAL to the device attributes. History shows that a high number of failures are directly traceable to faulty instructions.
The FDA CDRH considers poor instructions equal to a adulated product. See "Write it Right".
FDA views faulty instructions (take 100 aspirins as opposed to take 1 aspirin) as the same adulteration as having an adulterated product! From the patients prospective both cause the same possibility for adverse effects!
Prior to founding Compliance Consultants, we managed documentation systems on complex, large-scale, challenging -Department of Defense, NASA and various airborne weapons systems.
