Makromed, Inc.

Makromed, Inc. is a quality management system (QMS) software and regulatory affairs (RA) consulting firm serving the medical device, diagnostic, pharmaceutical, nutraceutical, and biotechnology industries. The company offers a comprehensive suite of cloud-based QMS software modules including InfoPV (Process/Test Method Validation), InfoSQA (Software Validation), InfoMed (Complaints/Adverse Events Management), InfoCAPA (Corrective/Preventive Actions), InfoAudit (Internal and Supplier Audits), and InfoTrain (Employee Training). In addition to software, Makromed provides specialized consulting services in process and test method validation, software validation, risk management, statistical techniques and biostatistics, design controls, CAPA implementation, Six Sigma tools, and regulatory compliance auditing. The firm also offers FDA-focused training through MyFDAcademy.com, an interactive online platform covering QMS and RA topics. With ISO 13485:2016 certification, Makromed serves as a trusted partner for companies navigating FDA QSR, MDR, and ISO 13485 requirements, including 510(k) and De Novo submission support for software-driven medical devices. The company's expertise spans design control, reliability analysis, and regulatory strategy for medical device manufacturers and service providers.