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Hello,
I am an experienced med device manufacturer/PM, who is working on a startup med device man company. My task is to create a quality system and implement a small cleanroom. We want to manufacture and package class II devices in small quantities. My questions are:
1. I know I need to establish a Design Control system. Any advice on where to obtain a template/example systems?
2. As for our manufacturing site, what guidance tells me ISO certifications are required? Is that part of the CE mark/510k process?
3. Do I have to perform the manufacturing in a clean room or a controlled environment?
I know these are very broad questions, but I just need to know where to start looking for answers. I don't want to go to an unknown consultant who is going to overcharge me too much for too little info...I need to arm myself with information before proceeding...Thanks for any advice!
I am an experienced med device manufacturer/PM, who is working on a startup med device man company. My task is to create a quality system and implement a small cleanroom. We want to manufacture and package class II devices in small quantities. My questions are:
1. I know I need to establish a Design Control system. Any advice on where to obtain a template/example systems?
2. As for our manufacturing site, what guidance tells me ISO certifications are required? Is that part of the CE mark/510k process?
3. Do I have to perform the manufacturing in a clean room or a controlled environment?
I know these are very broad questions, but I just need to know where to start looking for answers. I don't want to go to an unknown consultant who is going to overcharge me too much for too little info...I need to arm myself with information before proceeding...Thanks for any advice!
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If you have an interesting enough situation, I might be interested in it as a case study - see