When thinking about the roles of Quality Assurance (QA) and Regulatory Affairs (RA), I like to use the metaphor of the trail blazer and the guide, RA is there to blaze the trail and find the path, QA is there to keep the team on that path and away from pitfalls and hazards. RA does […]
Medical device projects generally have an S-Curve Model curve for costs. Low at the beginning, rising steeply in the middle and then flattening out towards completion. To manage costs, effort should always be put into the early stages of a project (or product development) to ensure that the project is as well defined as possible […]
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.
Editor’s note: This is the 2022 update to the August 2015 “5 Tips for medical device cyber security” blog by Vincent Crabtree. Read the original one here. In this modern world, cyber security and data protection has become a familiar topic to us all. From agreeing to cookies on website, to data privacy agreements to […]
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 […]
It’s always great to spend time with regulators to understand their point of view on the regulations and guidances they provide to us. It is also helpful to hear about the changes going on at Health Canada to gain insight into their roadmap for the future.