Compliance

Invivoscribe Technologies, Inc. conducts its business in compliance with the appropriate and applicable In-Vitro Diagnostic medical device regulations and standards for California, Europe, and US manufacturers and distributors.

The product development group follows established procedures compliant with both ISO 13485 and US FDA design control requirements.

The manufacturing of IVDs is accomplished in compliance with the US FDA Quality System Regulations, the State of California's Food and Drug Bureau's requirements and the ISO 13485 Medical Device Quality Systems Standard.

Our operations also comply with appropriate and applicable state and federal laws concerning safety (OSHA), hazardous waste (EPA) and animal source (USDA) requirements.

Invivoscribe's products are distributed in compliance with domestic (DOT) and export regulations as appropriate and applicable.  Our US IVD products are registered and labeled in compliance with the US FDA requirements.  Our CE Marked products are registered and labeled in compliance with the In-Vitro Diagnostic Medical Device Directive 98/79/EC.