compliance

REGULATORY COMPLIANCE

RADSpa® has gone through rigorous testing and evaluations of various compliance authorities. It is the constant endeavor of the team to keep the product within compliance guidelines and add new features to suit the market needs.

The product is approved by the FDA and CE authorities. The studies are also stored in a datacenter which is replicated at a disaster management location. The data center has been certified according to the SAS 70 Type II & SSAE 16/SOC 1 (The “New” SAS 70) requirements. This exceeds the stringent standards for security and operations that Sarbanes-Oxley, HIPAA, Gramm-Leach- Bliley and other regulations require.

FDA (Food and Drug Administration) is a government agency responsible for the safety of food, dietary supplements, human drugs, vaccines, blood products and other biologicals, medical devices, radiation-emitting electronics, cosmetics, veterinarian products and tobacco products being sold or manufactured in the United States.

Organizations that manufacture, re-pack or re-label products in the aforementioned industries must register with the FDA, except for cosmetics, where registration is voluntary.

CE marking is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA). The CE marking is also found on products sold outside the EEA that are manufactured in, or designed to be sold in, the EEA. This makes the CE marking recognizable worldwide even to people who are not familiar with the European Economic Area.

According to the U.S. Department of Health and Human Services (HHS), the HIPAA Privacy Rule, or Standards for Privacy of Individually Identifiable Health Information, establishes national standards for the protection of certain health information. Additionally, the Security Rule establishes a national set of security standards for protecting specific health information that is held or transferred in electronic form. Our datacenter has just passed a rigorous HIPAA Compliance Risk Assessment and met every requirement set forth by the U.S. Department of Health & Human Services.