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Risk Benefit

Jun 02, 2021

You’ve Evaluated Every Risk But Are You Properly Documenting Medical Device Benefits?

fda-21-cfr-part-11

Apr 23, 2021

FDA 21 CFR Part 11 Compliance: Are You Complying With These Four Critical Electronic Records Requirements?

EU MDR (2017/745) Update

Apr 01, 2021

Latest EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) Updates

Oriel STAT A MATRIX can help answer your questions about the Medical Device Single Audit Program.

Mar 29, 2021

MDSAP Mock Audits – Getting QA and RA on the Same Page

Feb 24, 2021

Virtual Medical Device Inspections and Audits: Here to Stay?

Jul 21, 2020

Overview of Medical Device Cybersecurity Standards and Guidance Documents