Lafayette, LA
Quoted from HHaase:I've worked in two facilities now that manufacture medical assemblies and electronics, and please don't take this as a dig against Stern (or any other pinball company), but they are not equipped to do that kind of manufacturing. It's mainly the company certifications, quality system requirements, and certified training requirements for the employee's that will hold them back. Getting a medical manufacturing certification such as ISO-13485 is a huge undertaking, especially if they don't have any of the ISO-9000/ISO-9001 framework in place.
-Hans
Hans,
To meet demand, can't a certified medical equipment company (XYZ) subcontract work to a company such as Stern, provided that XYZ has Stern follow their certified quality work procedures & processes, and Stern employees receive necessary training, with monitored oversight by XYZ to ensure compliance? Seems like that could be done in a matter of weeks if necessary.
