“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 […]
The FDA recently (April, 2023) came out with a draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software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 […]
The FDA requires a UDI in both plain text and machine-readable format (i.e., bar code) to be printed on a label that is attached to the device and the device packaging for traceability through distribution and service life of the device.
Pre-submission meetings are a good opportunity to interact with regulators, educate them on your technology and gather valuable feedback for your submission. However, if not properly planned or executed, the results of the meeting may frustrate sponsors and end up being and a waste of time for all involved.
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.
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 […]
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:
This blog explores in silico medical device drop testing VS traditional benchtop methods. Medical device design must address how a device is used and handled (e.g., handheld, benchtop, self-supporting, etc.).
We share our newest and most interesting blog posts in a monthly newsletter. Inevitably some articles prove more popular than others, so we have consolidated a list of the most read 2022 Medical Device Articles determined by our readers.
Two new articles made the list of our most-read blogs for 2022. They join eight from last year’s top 10 covering a variety of topics including perspectives on equipment sterilization, firmware testing, and the impact of certain standards and compliances on labeling and vendor selection.
StarFish Medical YouTube subscribers grew 50% in 2022. What medical device commercialization videos were they watching?
The medical device product definition process can make or break a novel medical device. Our experts discussed the topic and offered tips in a recent medical device product definition roundtable. Their tips range from general guidelines to regulatory, reimbursement, lean startups, architecture, and hazard management.
