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Hello all,
I am new to the forum and after several hours reviewing information here, decided to explicitly ask about some of the questions I had as I was still unclear about the answer.
My background is in Design and Development Engineering however I am currently working business development for a very small med device startup. Although I have seen a lot of the QS/cGMP at larger medical device companies, I have never been directly involved with their implementation.
We have already launched one successful product (which I was not involved with) and are in the development process with two more. I am tasked with the development of these 2 other products. Both products are very simple Class I devices that will be manufactured, packaged, sterilized, tested, and shipped to us by a contract manufacturer. We will be providing them with all of the specifications on the devices. Unfortunately, neither product will be exempt from GMP. All that our company will be doing is storing, marketing, selling, and delivering the final product delivered from the CM. Obviously this comes with servicing complaints as well.
If I am not mistaken, we would be the "specification developers" for the product, which requires us to maintain cGMP. Because of this, are we responsible for putting extensive quality systems in place that involve the manufacturing of the device or can some of this be passed off to the CM? I see us being involved in the distribution and complaint/servicing part of the QSR, but it seems that most of the manufacturing quality would be taking place with our CM. Are we able to pass off some of the quality systems to the CM or are we responsible for the entire thing?
As you can imagine, developing an entire QS as such a small company would introduce a huge strain onto our company. While I think I am capable of doing this, I would anticipate this taking over a year of work that would take a large amount of my time. Are there any ways to get out of developing a complete QS that includes all of the manufacturing as well?
Thank you in advance for any guidance you guys can provide on the topic!
I am new to the forum and after several hours reviewing information here, decided to explicitly ask about some of the questions I had as I was still unclear about the answer.
My background is in Design and Development Engineering however I am currently working business development for a very small med device startup. Although I have seen a lot of the QS/cGMP at larger medical device companies, I have never been directly involved with their implementation.
We have already launched one successful product (which I was not involved with) and are in the development process with two more. I am tasked with the development of these 2 other products. Both products are very simple Class I devices that will be manufactured, packaged, sterilized, tested, and shipped to us by a contract manufacturer. We will be providing them with all of the specifications on the devices. Unfortunately, neither product will be exempt from GMP. All that our company will be doing is storing, marketing, selling, and delivering the final product delivered from the CM. Obviously this comes with servicing complaints as well.
If I am not mistaken, we would be the "specification developers" for the product, which requires us to maintain cGMP. Because of this, are we responsible for putting extensive quality systems in place that involve the manufacturing of the device or can some of this be passed off to the CM? I see us being involved in the distribution and complaint/servicing part of the QSR, but it seems that most of the manufacturing quality would be taking place with our CM. Are we able to pass off some of the quality systems to the CM or are we responsible for the entire thing?
As you can imagine, developing an entire QS as such a small company would introduce a huge strain onto our company. While I think I am capable of doing this, I would anticipate this taking over a year of work that would take a large amount of my time. Are there any ways to get out of developing a complete QS that includes all of the manufacturing as well?
Thank you in advance for any guidance you guys can provide on the topic!