logo

QA/RA Consulting, Auditing & Training

logo

Let's get started

Blog

Storage Room

Jan 10, 2024

European Medical Device Importers and Distributors Have New Regulatory Responsibilities Under EU MDR Articles 13 and 14

Software as Medical Device

Jan 10, 2024

FDA and EU Risk Requirements for Medical Device Software & SaMD

Medical manufacturing

Jan 10, 2024

Understanding the Risks Posed by Your Medical Device Suppliers and How Supplier Quality Fits

FDA's Case for Quality

Jan 10, 2024

The US FDA Case for Quality (CfQ): What It Is and Why You Should Care

EU MDR TOC

Jan 10, 2024

Table of Contents for the EU MDR 2017/745

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

Jan 10, 2024

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