Medical device Auditor

Medical device auditor first need to know what is auditing process and practice. Usually, this kind of knowledge gets through the education for Lead auditor for ISO 9001 and/or ISO 13485. 

Then, medical device auditors need to have a background in manufacturing and/or designing certain types of medical devices. This is proved by CV and expert knowledge. Each medical device auditor is specified for certain types of medical devices, there is no any auditor that audits all types of medical devices. 

Medical devices are divided into codes.

A list of codes for the EU market that are under Medical device regulation MDR 2017/745 can be found on the following link: https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en, look for the document MDCG 2019-14 Explanatory note on MDR codes.

For USA market, codes for medical devices can be found on the following link: https://www.fda.gov/medical-devices/classify-your-medical-device/product-code-classification-database

Information about ISO 9001:2015 Lead Auditor Training Course you can find on following link https://advisera.com/training/iso-9001-lead-auditor-course/