QA/RA Consulting, Auditing & Training
Table of Contents for the EU MDR 2017/745 If you have downloaded the 175-page European Medical Device Regulation PDF but are frustrated that it does not contain a Table of Contents, Oriel STAT A MATRIX has come to your rescue. We have taken the official MDR regulation as published on May 5, 2017 and added […]
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MDSAP Mock Audits – Getting QA and RA on the Same Page As companies grow larger, they often split the responsibilities of QMS management and regulatory compliance. Typically, QA will handle ISO 13485, FDA QSR, product quality, CAPA compliance, and so on. Regulatory tends to manage product registrations, clinical evaluation reports, risk management, and the […]
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FDA QSR vs. QMSR: What Medical Device Manufacturers That DO NOT Have ISO 13485 Need to Know Short answer:├é┬áNo. Longer answer:├é┬áFrom a high-level perspective, the standards now differ in intent, content, and structure. ├é┬á A high-level look at the alignment between ISO 9001:2015 and ISO 13485:2016 ├é┬á Intent:├é┬áNot fully aligned The standards share one ultimate […]
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