HIPAA
HIPPA regulations applicable to organizations are HIPPA Privacy (Keeping PHI safe from people) and HIPPA Security (Keeping PHI especially electronic form from hackers, theft, disaster, etc.)
CE Marking
CE Marking is a certification mark that indicates conformity with health, safety, and environmental protection standards. It’s a recognizable standard worldwide.
21 CFR 820
21 CFR 820 is also known as medical devices GMP (Good manufacturing practices). These are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of devices.