logo

QA/RA Consulting, Auditing & Training

logo

Let's get started

Blog

EU MDR (2017/745) Update

Mar 03, 2018

Number of Notified Bodies Pursuing MDR and IVDR Certification Continues to Dwindle

Feb 02, 2018

What Will Happen to UK-Based Notified Bodies and Authorized Representatives after Brexit?

quality-system-harmonization

Sep 20, 2017

How Quality System Harmonization Supports Growth

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

Jul 21, 2017

MDSAP’s Process-Based Audit Approach & Sequence

Jun 22, 2017

CAPA and P&PC: How to Handle These Two Medical Device Compliance Troublemakers

Mar 17, 2017

FDA Proposes Expanding the List of 510(k) Exempt Devices: What You Need to Know