Makromed is a Delaware corporation that was founded in 1990 and is privately held. The company provides software products and consulting services for regulatory compliance to the medical devices, diagnostics and pharmaceutical industries. Makromed develops, manufactures, markets and supports software systems that address various requirements of the FDA s QSR/GMP regulation, European Union s MDD and international quality standards such as ISO 9000 and ISO 13485. These products include complaint handling and corrective action software, internal and vendor audit software, employee training software and more. Makromed offers consulting services for design, implementation and audits of QSR/GMP and ISO systems. The company s focus is on areas such as the software development life cycle, software QA, risk analysis and Part 11 compliance. The corporate office is in Salem, N.H. All product development, sales and technical support services are managed from this office. Sales and support services are offered in various regions through field personnel.
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