Posts categorized as“Quality”

Astero StarFish

10 Most Read New Medical Device Blogs in 2023

This year’s list of most read StarFish Medical blogs features the 10 most read blogs written in 2023 and the 10 most read employee written blogs during 2023 including some from back in 2014. Our new blogs include expertise and insights from three new authors, two group blogs and five articles from blogging veterans. Topics […]

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FDA Draft guidance: Marketing Submission PCCP Recommendations for AI/ML-Enabled Device Software Functions

The FDA recently (April, 2023) came out with a draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software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 […]

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:

Tess Carswell

Developing and Running an Industry-Integrated Human Factors Engineering Course

Although engineering students graduate from their program well-equipped with the theoretical concepts taught in class, they often lack practical knowledge regarding their particular industry [1]. Such gaps between technical teachings and industry requirements could potentially be filled by integrating an industry perspective into programs and course delivery. Further benefit can be derived when such industry-integrated […]

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