Posts categorized as“Regulatory”

Josh Coutts

Addressing ingress protection for home healthcare medical devices

What the standard says and what you should know. Increasingly medical device technology is filtering down from hospitals and into patients’ homes.  Designers need to understand and address the impact of this transition on the medical device design when addressing ingress protection for home healthcare medical devices 60601-1-11 Collateral Standard: Requirements for medical electrical equipment […]

Virginia Anastassova

FDA Breakthrough Devices Program Update and Advantages

The FDA Breakthrough Devices Program provides several advantages for novel devices that meet the inclusion criteria and can significantly reduce a product’s time to market. The Breakthrough Devices program implemented by FDA in 2018 has superseded the Expedited Access program that was introduced in 2015. The program is gaining popularity with 11 designations in 2016, 19 […]

Deborah Pinchev

COVID-19 Testing Authorizations in the US and Canada

This blog provides an overview of COVID-19 testing authorizations and developments of the COVID-19 pandemic in the United States and Canada. In the world of regulated health care products these tests are known as in vitro diagnostics (IVDs) and fall under the medical device definition in most jurisdictions. Almost 6 months since both the FDA […]

Helen Simons

Submitting a medical device application under the Health Canada Interim Order

Our experience submitting under the Health Canada Interim Order Prime Minister Trudeau announced StarFish Medical’s participation in the  NGEN Canadian Emergency Ventilators project on March 31, 2020, as part of Canada’s Plan to Mobilize Industry to Fight COVID-19. StarFish Medical was asked to help supply ventilators for the Canadian healthcare system and to develop them rapidly so […]

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.

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