Safeplus International Holdings Ltd. (ACAI)

[zenvesting]

Good question about Squiggle manufacturung. They'd need some GMP certified faclities to do it in....don't believe either BIPH or New Scale are there yet?

That would require either of them to comply with all applicable FDA regulations governing medical device manufacturing, including premarket notification (510(k)), premarket approval (PMA), medical device reporting (MDR), device labeling, good manufacturing practices (GMPs), establishment registration, and device listing.

Dealing with being inspected in accordance with the Quality System regulation, Title 21, Code of Federal Regulations (CFR), Part 820, and labeling requirements of 21 CFR Part 801.

Even something so simple like repackaging, relabeling, or sterilization activities (including any associated processing operations; e.g., cleaning) are required to comply with the Good Manufacturing Practice (GMP) and device labeling requirements of the Federal regulations, 21 CFR Parts 820 and 801.

Yep....sound like a lot of fun.....you wouldn't catch me fighting with a partner to control manufacturing rights!!! Thanks....we'll take the 49% net when you're done!