Antrix, Inc

Next Generation Regulatory, Clinical, Quality Assurance Consulting Services and Products for Medical Device, IVD, LDT, Software, and Digital Health Powered by AI, ML, and NLP Antrix provides unparalleled expertise in quality, clinical, and regulatory consulting services for diverse medical device specialties. We work with doctors in the respective medical specialty to get further insight into the intended use and patient safety. The regulatory pathway services include Pre-Submission, Q-Submission, Breakthrough device designation Premarket Notification 510(k), Premarket Approval (PMA), De Novo, Humanitarian Device Exemption (HDE), Custom Device Exemption (CDE), Expanded Access Program (EAP), Product Development Protocol (PDP) and EU CE MDR and IVDR technical file approval and registrations. Antrix have experts who specialize in digital health technology regulatory requirements for Cybersecurity, Augmented Reality / Virtual Reality in medical devices, Wireless, and Artificial Intelligence and Machine Learning in Software as a Medical Device including Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions. Antrix consultants have excellent knowledge of In Vitro Diagnostic (IVD) devices which include instruments, reagents, DNA, protein and peptide microarray, and software. 1. Setup a Quality Management System and Procedures for ISO 13485, ISO 9001, ISO 15189, ISO 27001, MDSAP, EU MDR 2017/745, EU IVDR 2017/746, CLIA, CAP, NYSDOH, ISO 22716, ISO 22000, NSF-2, NSF-3, FDA CFR Part 210, 211, 600 2. Develop a comprehensive product regulatory strategy and submissions plan, ensuring compliance with EU, FDA, ROW and ISO 14971 risk analysis, ISO 62366 usability studies, ISO 62304 software compliance, Analytical and Clinical Study 3. Develop Product Post Market Surveillance, Vigilance, Complaints, and Field Actions Process and Procedures