Calibration Services in Florida

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.

FDAbasics is a full-service FDA compliance and regulatory consulting firm with 30+ years of experience serving food, drug, medical device, and cosmetic manufacturers worldwide. The company specializes in US Agent appointment and representation for foreign companies, FDA facility registration and renewal, product listing and labeling compliance reviews, NDC/GUDID submissions, 510(k) support, DMF filings, ANDA/IND/NDA application assistance, MoCRA compliance, FSVP compliance for food importers, and GDUFA self-identification for generic drug manufacturers. FDAbasics maintains a US-based team in Brooklyn, NY, offering transparent pricing, rapid registration turnaround (2 business days), and comprehensive regulatory support across all four FDA-regulated industries. The firm is 5-star rated on Trustpilot and Google, serving clients in 100+ countries.