I am part of a start up medical device company. We design, validate and sell FDA class 1 exempt devices in orthopedics. I am new to this arena and looking for help. Our manufacturing has all its FDA cert and so on, but as a device company what FDA cert do we need? I need to develop a Quality Assurance/control program for incoming product prior to selling, any suggestions on a template/program to start with?
Thanks for your help
J
Hi Jeff and welcome to the Cove!
I moved this thread to the ISO 13485 - Medical Devices forum since your question pertains to medical devices. This should allow better response.
By "FDA cert" do you mean your company's establishment registration? I'm not aware of any kind of certification that the FDA does for medical device companies.
However, if you're looking for information on how to become registered/certified to an ISO standard and which standard is applicable, then you've come to the right place!

There is a wealth of information here. Have you done a search in the Post Attachments List (the thin green bar in the upper left corner of this screen) for any templates you may need? There are ppt presentations, documents, templates, spreadsheets, etc. posted there that you could peruse and perhaps find something that will work for your organization (with a little bit of tweaking where necessary, and giving credit where applicable

).
What is your part/role in the organization? Are you responsible for developing the quality system, or do you have management responsibility? How large/small is your company? Will you have management support in developing and implementing your quality system? These are things to consider, as well. Management support is crucial to this effort!
I hope this helps. I'm sure there are others here who will offer more advice, too. Again, welcome to the Cove!
