A Delaware corporation, founded in 1990, privately held stock.
Provide software products and consulting services for quality and regulatory compliance to the medical device, diagnostic, 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 MDR, and international quality standards such as ISO 9000 and ISO 13485. These products include software for process and test method validation, software validation, complaint and adverse event handling, corrective and preventive action, internal and supplier audits, and employee training.
Makromed offers consulting services for design, implementation, and audits of QSR/GMP and ISO systems. Our focus is on such areas as process/test method validations, software validations, risk management, statistical techniques, design controls, CAPA's, QMS audits and training, and 510(k) submissions.
Makromed's primary customers are medical device, diagnostic, and pharmaceutical companies. Makromed's products are installed worldwide, including USA, UK, Germany, France, Ireland, Denmark, Norway, Italy, Japan, Malaysia, and Singapore.
Corporate and Support Offices
The corporate office is in Salem, NH, 30 miles north of Boston. 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. Makromed Costa Rica was established in 2011 to give service and support to Latin America in English and Spanish.
Makromed's quality policy is "practice what you preach". Our QMS is ISO 13485 certified.