Makromed Inc. Email Format

Medical Equipment ManufacturingNew Hampshire, United States11-50 Employees

Makromed Inc. is a Salem, New Hampshire-based provider delivering quality management system software solutions and regulatory consulting for companies in FDA-regulated industries. The firm serves a broad range of clients, from startups to Fortune 500 companies, helping them achieve high product quality and regulatory compliance; it is ISO 13485:2016 registered, aligning with customers' quality objectives. A group of experienced professionals leads Makromed, combining software development with advisory services to navigate the complexities of medical-device quality systems. Its software offerings are designed to support compliance with FDA QSR/GMP, EU MDR, and international standards, covering areas such as process validation, software validation, CAPA, audits, and training within a unified QMS. In addition to software, Makromed provides consulting services focused on new product development and regulatory submissions, including design controls, risk management, testing, and documentation for software-driven devices. The company also operates MyFDAAcademy.com, an e-learning center offering FDA-related quality, regulatory, and compliance training.

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