Helen Erwood
Helen Erwood is Director, Global Regulatory Affairs, ESPL Regulatory Consulting. She is a Regulatory Affairs professional with more than 30 years experience in the pharmaceuticals / device industry.
Meeting ReportMD3: Digitalisation: How to bring paradise into regulatory work
Martin Witte chaired and introduced this interesting session, which considered the digitalisation of medical device regulatory information –using technology to allow more effective interrogation and control of available data…
Meeting ReportIVD5: How do I Implement IVDR? Some key practicalities
This session looked at the practicalities of IVDR implementation and considered how to prepare application documents, the expectations for performance evaluation (PE) and postmarketing clinical follow-up (PMCF).