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QA/RA Consulting, Auditing & Training

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Jan 28, 2022

How to Prepare for and Conduct an ISO 13485 Internal QMS Audit

Oct 12, 2021

eLabeling and eIFU Requirements Under the EU MDR and Regulation 2021/2226

Aug 02, 2021

ISO 14971:2019: Understanding the Current Version of ISO 14971

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?

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