logo

QA/RA Consulting, Auditing & Training

logo

Let's get started

Jan 12, 2024

Pharma Process Validation: Where Do We Start?

Jan 12, 2024

Drug, Device, or Both? Overview of FDA Premarket Regulation of Combination Products

Jan 12, 2024

Medical Device & IVD Usability Testing and FDA Human Factors Requirements

Jan 12, 2024

FDA Regulatory Requirements for Medical Device Software (SaMD and SiMD)

Jan 12, 2024

Still Maintaining Duplicate MDD/MDR and IVDD/IVDR Documentation?

software terms on chalkboard with man in suit looking at it

Jan 12, 2024

Understanding IEC/ISO 62304 and FDA Requirements for Medical Device Software Development Life Cycle (SDLC) Management