Posts by Helen Simons

Helen Simons

Inspiring Inclusion – Women in STEM

This year’s International Women’s day theme is ‘Inspire Inclusion’. In this blog I’ll share statistics around women in Science, Technology, Engineering and Mathematics (STEM) and the inspiration I’ve gained from inclusion improvements during my career.

Helen Simons

4 Regulatory Trends to Watch In 2024

FDA Quality Management System Regulation (QMSR) In February 2022, FDA released proposals for aligning their Quality System Regulation (QSR) with the commonly used ISO 13485 Medical devices – Quality management systems[1] – Requirements for regulatory purposes. This had been long awaited and was rumoured to be coming for many years prior to this point. As […]

Helen Simons

New Cybersecurity Requirements in the US

Cybersecurity is a key consideration in today’s market for medical device manufacturers and other industries. I have previously written about the FDA’s expectations for cybersecurity documentation for medical device submissions, and spoken about this topic at Medical Device Playbook Toronto.

Helen Simons

Submitting a medical device application under the Health Canada Interim Order

Our experience submitting under the Health Canada Interim Order Prime Minister Trudeau announced StarFish Medical’s participation in the  NGEN Canadian Emergency Ventilators project on March 31, 2020, as part of Canada’s Plan to Mobilize Industry to Fight COVID-19. StarFish Medical was asked to help supply ventilators for the Canadian healthcare system and to develop them rapidly so […]

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