Makromed, Inc.: Complaint Handling and Adverse Event, CAPA and Nonconformance, Employee Training, Internal and Supplier Audit Software and Regulatory Consulting

We provide Software Products and Consulting Services related to Quality and Regulatory compliance to our customers in the Medical Device, Diagnostics, and Pharmaceutical industries.

Our Products		Our Services

InfoMed	Complaint Handling and Adverse Event Reporting Software with full eMDR Support	Audits	Quality System audits and assessment: GMP, QSR, Part 11, MDD
InfoCAPA	CAPA (Corrective and Preventive Action) and Nonconformance Software	Validation	Software development life cycle, software validation, IQ/OQ/PQ
InfoAudit	Internal and Supplier Audit Software	Risk Analysis	Product, process, and software risk analysis (FTA and FMEA)
InfoTrain	Employee Training Software	Training	Quality systems, validation, risk analysis, design controls
InfoSQA	Software Quality Assurance	Implementation	Quality systems, quality manual, SOPs
InfoPV	Process Validation and Test Method Validation Software -- Now Available!	Software Services	510(k)s, audits, Part 11 compliance, risk analysis, validation, QA training

Full web application versions of InfoAudit and InfoPV are now ready to order! Click here for more information on InfoPV.

We now have an office in Costa Rica to serve Latin America! Click here for Makromed Costa Rica.

MyFDA Academy e-Learning Center is now online!
MyFDA Academy is an e-learning center where people involved in the medical device, pharmaceutical, and biotech industries can take online training courses on a variety of topics relevant to the Quality Management System and/or Regulatory Compliance aspects of these industries. Check it out here.