Posts categorized as“Regulatory”

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.

Alexandra Reid

FDA and Health Canada streamline medical device submissions with joint eSTAR portal

The U.S. Food and Drug Administration (FDA) is partnering with Health Canada to launch a joint electronic Submission Template and Resource (eSTAR) pilot. The joint pilot, announced on January 10th, 2023, will test the feasibility of allowing sponsors to submit medical device submissions to both regulatory bodies through the FDA’s eSTAR online portal. Requests for […]

Astero StarFish

Medical Device Commercialization Resolutions for 2023

Have you made your medical device commercialization resolutions for 2023? We polled our quality, regulatory, project management, manufacturing, and engineering experts for their New Year resolutions. De-risking early, communicating often, testing, and managing pivots were top themes for 2023. Read their medical device commercialization resolutions below:

Deborah Pinchev

UK Medical Device Brexit Implications

On June 26, 2022, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released the Government response to consultation on the future regulation of medical devices in the United Kingdom. This response will effectively guide the UK’s post-Brexit implementation plan for medical device regulation. The following are high-level key points that are sure to be […]

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