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I am looking to gain more experience in auditing in a team. How does one get their name and credentials out in the Medical Device Quality Auditing space to gain experience? I have both MDSAP internal auditor and ISO13485 Lead Auditor certificates through Exemplar Global. Are there networking communities ...

For audits such as ISO13485 and MDSAP, I have a checklist of required documents, a checklist of required records and a list of recommended implementation evidence for each clause. It is a helpful starting tool before diving deeper into the potential findings. ------------------------------ Nanda Filkin ...

I would appreciate if someone can assist me adding my Credly badges to my profile page. Thanks.

My biggest piece of advice is be prepared for an audit with a template in which to take notes. So much information will be shared and there is not enough time to document everything, so learn to pick the the most relevant thread and follow that thread with thorough notes. If notes are not thorough enough ...

I work in the Medical Device Industry (now in Quality Assurance and formerly as R&D Scientist and Product Scientist). One big lesson that comes to mind for me is that a quality procedure can be written to meet the standards and follow the regulations, but if it isn't relevant for the person following ...