Blog

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?

Aug 02, 2021

ISO 14971:2019: Understanding the Current Version of ISO 14971

Jul 20, 2021

Writing NPS Protocols and Testing for Medical Device Manufacturers