B
Bomiss
Hello All,
Thanks to everyone for participating on this form. The participation allows the novice (like me) to gain a better understanding through the discussions. I have been reading the content for a few weeks and I am impressed, not only about the knowledge content, but also the considerate approach to finding resolution to the questions proposed on the forum.
Now for the issue I have at hand, I would appreciate a better understanding of the Design requirements for ISO 13485. I have recently started a new business and I need validation on my perception of Design Exclusions in regard to ISO 13485. The FDA’s GMP CFR 820 standard states that Class I and some Class II medical devices are excluded from Design Controls. The product I manufacture is a class I, non-invasive, non-sterile, plastic/rubber medical device used in Dentistry. The product category is not listed in the chart of Class I Medical devices that have to have Design Controls.
It is my interpretation, that even if I designed the product, I would not need to use design Controls in my business. At this time, we are a very small company and all Design, Engineering, Quality, and other business functions are managed by one person.
If I am misled please help me understand.
Thanks
Thanks to everyone for participating on this form. The participation allows the novice (like me) to gain a better understanding through the discussions. I have been reading the content for a few weeks and I am impressed, not only about the knowledge content, but also the considerate approach to finding resolution to the questions proposed on the forum.
Now for the issue I have at hand, I would appreciate a better understanding of the Design requirements for ISO 13485. I have recently started a new business and I need validation on my perception of Design Exclusions in regard to ISO 13485. The FDA’s GMP CFR 820 standard states that Class I and some Class II medical devices are excluded from Design Controls. The product I manufacture is a class I, non-invasive, non-sterile, plastic/rubber medical device used in Dentistry. The product category is not listed in the chart of Class I Medical devices that have to have Design Controls.
It is my interpretation, that even if I designed the product, I would not need to use design Controls in my business. At this time, we are a very small company and all Design, Engineering, Quality, and other business functions are managed by one person.
If I am misled please help me understand.
Thanks