Do note the vaccine testing skipped the normal animal testing phase and went straight to human trials.
I'm pretty sure the regulator is willing to work with you. Also you should contact them now. It is actually possible you can tap into a lot of incidental industry experience if they point you toward someone who has spent a lot of time doing medical equipment certs or ventilator certs before.
I'm pretty sure the regulator is willing to work with you. Also you should contact them now. It is actually possible you can tap into a lot of incidental industry experience if they point you toward someone who has spent a lot of time doing medical equipment certs or ventilator certs before.