Start Up Medical Device Company - As a device company what FDA cert do we need?

J

Jeff EORL

#1
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
 
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GStough

Staff member
Super Moderator
#2
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! :bigwave:

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! :bigwave:
 
J

Jeff EORL

#5
Thanks for all the input. You are right...this place is great! Here is my story. I am a orthopedic Physician Assistant by trade. The doctor that I work with and I developed some instruments for our use in surgery. Other orthopedic surgeons saw and liked what we made so...we started a medical device company. He is CEO and I am COO. There are three people that make up the company (so we are small to say the least). Learning curve is steep, but fun so far.

I am responsible for the quality system as well as management:mg: so I am here to learn. I would like to eventually be certified to an ISO standard once I can learn how. Right now more questions than time. We are importing some simple pieces from other countries but most is made here. Any hints/tips with importing product? I will check out the FDA site thanks. Also thanks for the idea about the little green bar i will take a look.

any advice is appreciated!!

J:thanks:
 

yodon

Staff member
Super Moderator
#6
Jeff,

As you develop your quality system, you may feel inclined to look for help. There are plenty of companies that will sell you a "package" to implement your quality system. Often, these are very generally written and can be applied to mega-corps. These are typically not too good for a 3-person shop. We had one client of ~25 employees who bought such a package and it ended up calling for more committees than they had employees. And the processes defined by the package were similarly complex - again, ill-suited for their shop. Most of these packages can be tailored to suit your environment but just be careful if you venture out in this.

As far as getting an ISO cert, since you are developing a medical device, look at ISO 13485.

Another word of caution: do NOT underestimate the effort to get a medical device cleared through the FDA. It is costly, takes time, and can be tough. Establish design controls early and understand the QSR.

As a small shop, I presume you'll outsource the manufacturing so be sure to go with one that has previous medical device manufacturing experience.

Best of luck and keep us posted on your progress.
 
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