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Hello Trevor, I am based in southeast Ohio (not Maryland but close depending on what part of Maryland you are in) if you are still looking for an auditor. I have certification in both ISO13485 (lead auditor) and MDSAP (internal auditor) and am familiar with EU MDR reporting guidelines. Most of my audits ...

Hello Exemplar Community, Over the last year, I worked hard to obtain my certification in ISO13485 and MDSAP through Exemplar Global. With over 20 years of benchtop experience in Research and Development and IVD and medical device development and manufacturing, I can provide a thorough perspective ...

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.