Posts categorized as“Regulatory”

Astero StarFish

Unpacking the Potential of 6 Medtech Trends

“AI seems to be a thing. Everybody’s excited about ChatGPT.” Asking ChatGPT to list current medical device trends as preparation for our monthly content meeting has turned into our latest group blog. Not surprisingly, the StarFish team identified the same trends proposed by ChatGPT- and more – with six of the most interesting trends making […]

Taimoor Khan

FDA Draft guidance: Marketing Submission PCCP Recommendations for AI/ML-Enabled Device Software Functions

The FDA recently (April, 2023) came out with a draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions. The document provides guidance for developing a Predetermined Change Control Plan (PCCP) for managing changes to the device software functions. The PCCP is a critical component of […]

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:

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