Wow, thanks to everyone for the great feedback!
Ronen E:
We currently take an exclusion on sterilization and implantable devices. Because at some point we may make an actual device (perhaps a beam therapy device or a surgical robot) I think the leaning is to not exclude at this time but it is under consideration.
We are both 9001 & 13485 certified currently.
Sagai:
It is not currently a customer mandate however within several of the fields in which we work customers will only consider us for contracts if we have the certification. It allows us to work with a broader spectrum of customers and prepares us for meeting contractual requirements like you mentioned.
Somashekar:
It is the last bit of the quote that drove us to 13485
?design, development, and provision of related services.
It can also be used by internal and external parties, including certification bodies, to assess the organization?s ability to meet customer and regulatory requirements.? We work in many fields ranging from semiconductor and electron microscopy to machines for handling nonwovens, medical materials, medical device testing, packaging and other related fields. As a rule we do not ever make anything that would be used on a patient or by an end consumer, we make the machines that a medical (device) company would use to produce their devices, consumables and related products.
Again, thanks to everyone for their feedback! As I said, I am very new to the QMS world and have a ton to learn.
Any advice or suggestions are very welcomed!
