Posts categorized as“Regulatory”

Astero StarFish

Where do you find inspiration for work?

Many have paused work for a COVID-19 required break. As an essential business, our work did not pause.  We asked our content team of engineers, regulatory, quality, design, and program management creative professionals where they find inspiration for their contributions to medical device development. This blog is about finding inspiration for your work as summer […]

Nigel Syrotuck

DIY COVID-19 Medical Devices

One response to possible COVID-19 medical device shortages is to try to hack DIY COVID-19 medical devices together. It’s very empowering to see open-source communities come together to try to turn out a workable design to help avoid dire shortages for those in need. However, development of medical devices is far more nuanced than it […]

Alexandra Reid

FDA Guidance on Non-Clinical Bench Performance Testing Information

Your Roadmap for Premarket Submissions Are you wondering how best to organize your test plans and reports to make them submission ready? Look no further. The FDA provides a roadmap to follow for your premarket submission in their new guidance, ‘Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions’.

Azra Rajwani

Big changes in ISO 14971:2019

Changes in ISO 14971:2019 mean a big change to the medical device industry. ISO 14971:2019 was released mid-December, and the EN version was released on December 18, 2019. The last time this standard was released was 2012, so buckle up folks because this new Risk Management Standard is going to be one roller-coaster ride.

Astero StarFish

Top 10 medical device commercialization lessons and tips

We asked our development and commercialization experts to share their top medical device commercialization lessons and tips based upon actual medical device development and commercialization experiences.  Their recommendations cover projects from working at StarFish as well as other medical device organizations.  Many include links to blogs with additional information. Here are 10 ideas to increase […]

Alexandra Reid

Bringing Consistency to the FDA’s Inspection Process

Leveling the Playing Field with recent Draft Guidance Review and Update of Device Establishment Inspection Processes and Standards, a draft guidance document from the FDA, establishes uniform processes and standards for FDA’s Inspection Process of both domestic and foreign medical device firms. The FDA’s plan is outlined in a short, six-page document released March 29, […]

Virginia Anastassova

510(k) submission: 9 Tips for success

A 510(k) submission is required in the U.S.to receive clearance to market almost all class II medical devices.  While the 510(k) preparation process is not as onerous as preparing a Premarket Approval (PMA), it has its own challenges and pitfalls. We recently completed a 510(k) submission and I’d like to share some of the wisdom […]

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