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Blog

Apr 03, 2022

Understanding EU IVD Performance Evaluation Plan and Report Requirements in the IVDR

state of the art

Mar 22, 2022

State of the Art in the EU MDR: What Does That Actually Mean?

Jan 28, 2022

How to Prepare for and Conduct an ISO 13485 Internal QMS Audit

Oct 12, 2021

eLabeling and eIFU Requirements Under the EU MDR and Regulation 2021/2226

Aug 23, 2021

Will Your Team Be Ready for a (Live and In-Person) FDA Medical Device Inspection?

Aug 16, 2021

When Will FDA Resume Medical Device Inspections?