Posts categorized as“Quality”

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FDA Draft guidance: Marketing Submission PCCP Recommendations for AI/ML-Enabled Device Software Functions

The FDA recently (April, 2023) came out with a draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software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

Astero StarFish

Our 10 most read medical device commercialization blogs of 2021

Two new medical device commercialization blogs, one returning champion, and two new authors join our 2021 “most read” list. Electrical engineering amd regulatory articles tie for the most popular blog topics. Many thanks to our employee authors past and present for sharing their insights and experience with medical device colleagues.

Azra Rajwani

Pros and Cons of Virtual Audits

Over the last year and a half, so many things have changed. We’ve had to adopt new practices to ensure the safety and wellbeing of not only ourselves, but also our friends, family and the general public. Aside from working from home, one big change for medical device manufacturers is in auditing. We’ve completely shifted […]

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