Oxavita S.R.L.

Sigma Biomedical is a medical technology development and consulting firm headquartered in Hialeah, Florida, with roots in biomedical research at Germany's Fraunhofer Institute. The company specializes in FDA regulatory consulting, medical device compliance, product safety and performance testing, and quality management system implementation. Sigma assists manufacturers and academic institutions navigating US and international medical device regulations, including 510(k) premarket notifications, device classification, and compliance with 21 CFR 820 (cGMP) and ISO 13485 standards. The firm offers comprehensive support for medical device registration, product testing validation against FDA-recognized consensus standards, GAP analysis for quality systems, and regulatory training programs. Sigma also provides cloud-based medical informatics and telemedicine solutions in select Latin American markets to improve healthcare access and operational efficiency.