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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

EU MDR & IVDR Updates

Jan 12, 2024

Which EU Notified Bodies Have Been “Designated” Under the MDR 2017/745 and IVDR 2017/746?

Jan 12, 2024

MDCG 2022-6: Making Changes to Legacy Devices Without Triggering EU IVDR Compliance

Jan 12, 2024

Supplementing Your Medical Device PMS Efforts with Online Data

Jan 12, 2024

Preparing for a Notified Body Medical Device Clinical Audit