Corporate Profile

Corporation

A Delaware corporation, founded in 1990, privately held stock.

Business

Provide software products and consulting services for quality and regulatory compliance to the medical devices, diagnostics and pharmaceutical industries.

Software Products

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 many more.

Consulting Services

Makromed offers consulting services for design, implementation and audits of QSR/GMP and ISO systems. Our focus is on such areas as the software development life cycle (SDLC), software QA, risk analysis, and Part 11 compliance.

Client Base

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. Hundreds of systems on varying computer environments.

Corporate and Support Offices

The corporate office is in Salem, NH, 30 miles from 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.

Quality Policy

Makromed’s quality policy is "practice what you preach". Makromed adheres to the quality standards of ISO 9000 and ISO 13485, and we are ISO 13485 certified.