Regulatory

Epilog is dedicated to provide its solutions fully compliant with the regulations.


 

Epilog’s solutions conform to the requirement of the FDA to be marketed. FDA stands for the U.S. Food and Drug Administration, an agency of the United States Department of Health and Human services. The FDA legislation protects the public health through the regulation and supervision of food and medical products. Our products are in compliance with the Federal Food, Drug and Cosmetic Act (FD&C Act) Code of Federal Regulations Title 21 part 808/812/820.

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Epilog’s solutions conform to the requirements of the Council Directive regarding theharmonization of statutory requirements of the member states on Medical Devices 93/42/ECC (MDD).

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ISO is the International Organization for Standardization. ISO facilitates and supports international trade by developing standards. These standards are recognized and respected worldwide. Orfit Industries is certified for the Quality Management System ISO 13485 (2016).

In progress

Epilog’s platform is fully compliant with the GDPR regulations in Europe and HIPAA regulations in the US.