Posts categorized as“Regulatory”

James Sease

The Value of SBOMs and SBOM Analysis

The FDA recently published a new guidance on Cybersecurity and software in medical devices: “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions”. The new guidance has pushed software composition and vulnerabilities up in importance when making a submission to the FDA. As such, Software Bills of Materials (SBOMs) have become a […]

Russell Haley

Overview of the New FDA Guidance on Cybersecurity

“Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions | FDA” is a new document produced by the FDA that provides guidance on integrating cybersecurity into the quality system management and premarket submission process for medical devices. It covers risk management, design controls, software validation, and other elements to ensure the safety, […]

Palash Jha

How Post-Market Surveillance Enhances Medical Device Safety

Understanding Post-Market Surveillance: In the fast-paced world of medical technology, the journey of a medical device doesn’t end with regulatory approval. It continues into the post-market phase, where vigilant surveillance becomes paramount. This blog delves into the significance of post-market surveillance (PMS) for medical devices, exploring its importance, challenges, and potential improvements.

Sean Mitchell

ESG Medical Device Impact

As major buyers continue to request Environmental, Social and Governance (ESG) reporting from suppliers, there will continue to be new and revised regulations requiring supply chain attention. Jurisdictions all over the world are increasingly enacting regulations aimed at curtailing the use, import and/or export of certain substances in response to political, environmental and social responsibility […]

Helen Simons

4 Regulatory Trends to Watch In 2024

FDA Quality Management System Regulation (QMSR) In February 2022, FDA released proposals for aligning their Quality System Regulation (QSR) with the commonly used ISO 13485 Medical devices – Quality management systems[1] – Requirements for regulatory purposes. This had been long awaited and was rumoured to be coming for many years prior to this point. As […]

Alexandra Reid

5 Key Points in FDA’s Real-World Evidence Draft Guidance

The FDA is making significant strides in integrating real-world data (RWD) into the regulatory framework for medical devices. A recent 40 page draft guidance, “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices” issued by the FDA elaborates on how real-world evidence (RWE) can be effectively used in regulatory decision-making for medical devices.

Astero StarFish

Our Top 10 Medical Device Videos of 2023

The number of StarFish Medical YouTube subscribers grew by 32% in 2023 and social media views increased an amazing 100%. This round-up features the 10 most viewed Medical Device videos that we created in 2023. Our 2023 top 10 medical device commercialization videos cover a variety of medical device commercialization topics ranging from Prototyping Proof […]

Astero StarFish

Top 10 Medtech Entrepreneur Webinars of 2023

Our first Medical Device Playbook Webinar debuted on July 24, 2020. Created to fill a vacuum created when live events were halted by COVID -19. The first MDPlaybook Medtech Entrepreneur Webinar covered How COVID-19 is Changing Medical Device Commercialization, a fitting topic if ever there was one. Since then, monthly webinars feature medtech executives, serial […]

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 […]

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