Posts categorized as“Quality”

May 1

Taimoor Khan in Eastern Region, Quality, Regulatory | No comments

FDA Draft guidance: Marketing Submission PCCP Recommendations for AI/ML-Enabled Device Software Functions

The FDA recently (April, 2023) came out with a draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software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

Jan 12

Astero StarFish in Business, Engineering, Manufacturing, Project Management, Quality, Regulatory | No comments

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:

Dec 5

Astero StarFish in Engineering, Industrial Design, Manufacturing, Product Development, Project Management, Quality, Regulatory | No comments

Most Read 2022 Medical Device Articles

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.

Dec 5

Astero StarFish in Engineering, Manufacturing, Product Development, Quality, Regulatory | No comments

2022 Top Medical Device Blogs

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.

Dec 2

Astero StarFish in Biotech, Business, Engineering, Entrepreneur, Manufacturing, NPI Commercialization, Quality, Regulatory, Uncategorized | No comments

2022 Top 10 Medical Device Commercialization Videos

StarFish Medical YouTube subscribers grew 50% in 2022. What medical device commercialization videos were they watching?

Oct 1

Astero StarFish in Industrial Design, Manufacturing, Optics, Product Development, Quality, Regulatory | 1 comment

7 New Developments That Impact Medical Devices

We recently asked our engineering and QA/RA leaders which new developments are likely to impact medical devices in the near- and long-term future. Their responses cover a variety of technology, regulatory, and supply chain activities.

Oct 1

Raje-Virginia in Industrial Design, Product Development, Project Management, Quality, Regulatory | 2 comments

ALARP to AFAP, the MDR and ISO 14971:2019+A11:2021

The risk management approach ALARP (As Low As Reasonably Practicable) to AFAP (As Far As Possible) and medical device risk management has always been a tricky one. The nature of the products, their intended use, and the markets in which they are sold influences the approaches in controlling risk. When it comes to risk, the […]

Feb 1

Tess Carswell in Engineering, Industrial Design, Product Development, Project Management, Quality, StarFish Culture | No comments

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 […]

Jan 1

Taimoor Khan in Eastern Region, Quality, Regulatory | No comments

FDA Action Plan for AI/ML in SaMD (Software as a Medical Device)

Artificial intelligence (AI) and machine learning (ML) technologies have a huge potential to change the way we look at our current health care practices. AI/ML enable new insights derived from the huge amount of data that is collected every day in the health care sector. This blog provides an overview of the FDA action plan […]

Dec 1

Astero StarFish in Engineering, Entrepreneur, Manufacturing, Product Development, Quality, Regulatory | No comments

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.

Sep 3

Azra Rajwani in Business, Quality, Regulatory | No comments

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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