J
jennaleeb
Hi everyone! Thanks to everyone who contributes to this forum, it is so valuable.
My question is in regards to meeting the essential requirements. We are a small start-up that makes a Class I non-sterile medical device. We are working towards ISO 13485 but in the mean time are also hoping to place the product on the market. In order to meet the ERs, as I understand it, the easiest way is just to refer to your ISO certification.
BUT! If we aren't ISO certified by the time we are ready to self-register, how does one demonstrate compliance? Refer to our risk reports/clinical evaluation/etc?
Does anyone have experience doing this without ISO 13485 certification?
Thanks!
Jenna
My question is in regards to meeting the essential requirements. We are a small start-up that makes a Class I non-sterile medical device. We are working towards ISO 13485 but in the mean time are also hoping to place the product on the market. In order to meet the ERs, as I understand it, the easiest way is just to refer to your ISO certification.
BUT! If we aren't ISO certified by the time we are ready to self-register, how does one demonstrate compliance? Refer to our risk reports/clinical evaluation/etc?
Does anyone have experience doing this without ISO 13485 certification?
Thanks!
Jenna