Re: ISO 13485 Certification - Device Technical File in conjunction with QMS developme
ScottK,
Thank you!!! That is exactly the start I needed. We do have a consultant lined up, but wanted to prepare as much as possible up front.
MIREGMGR,
Thank you kindly, but our "equipment" is more complex than I can discuss here. I am aware of international regs and their "appropriate" definitions. I stated correctly, that currently it is not classified as a medical device. FDA, EU, and Health Canada are all good with that as it stands. In the future, it is possible, that as the equipment changes, it may be considered a medical device. We believe in being prepared.