David OcaeiroGAP analysis in QMSPerfect, now when you have learned about the ISO 13485 standard with the help of 20 lessons explained on this website, now you are ready…Oct 2, 2020Oct 2, 2020
David OcaeiroAll you need to know about class II medical devicesIn the previous article, we were talking about Class I medical devices. So, what is the basic difference between class I and Class II, in…Aug 18, 2020Aug 18, 2020
David OcaeiroAll that you need to know about Medical devices class IMedical devices are devices whose purpose is to benefit patients. They are usually used by doctors and healthcare providers to help them…Jul 10, 2020Jul 10, 2020
David OcaeiroHow important is the traceability matrix in the medical device industry?The Traceability Matrix is important for various reasons. It is particularly significant to an FDA submission and CE Mark. It’s a…May 26, 2020May 26, 2020
David OcaeiroThis is why you need to implement QMSSo, you probably once come to the question, why would your business need a Quality Management System? Many people think that it’s a…May 11, 2020May 11, 2020
David Ocaeiro8 Most common question and answers in MedDev industry1. Is A Pre-submission a good idea or a bad idea?Apr 30, 2020Apr 30, 2020
David OcaeiroWhat do you need to become a QMS consultant for medical devices 2Our focus is on becoming a QMS consultant for medical device companies.Apr 21, 2020Apr 21, 2020
David OcaeiroWhat do you need to become QMS consultant for medical devices 1If you want to become a QMS consultant, you need to knowApr 16, 2020Apr 16, 2020