MyFDA Academy

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


Complaint Handling and Adverse Event Reporting Software with full eMDR Support


Quality System audits and assessment: GMP, QSR, Part 11, MDD


CAPA (Corrective and Preventive Action) and Nonconformance Software


Software development life cycle, software validation, IQ/OQ/PQ


Internal and Supplier Audit Software

Risk Analysis

Product, process, and software risk analysis (FTA and FMEA)


Employee Training Software


Quality systems, validation, risk analysis, design controls


Software Quality Assurance / Software Development and Validation


Quality systems, quality manual, SOPs


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.

Latin America offices in Costa Rica since 2011.

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.

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