Posts categorized as“Quality”

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 […]

Tara Lysechko

Update on Health Canada Activities and Changes

Keeping current with Health Canada’s medical device regulatory developments Over the course of the last year and a half, the number of accomplishments that Health Canada has achieved both in urgent response to the COVID-19 pandemic and towards priority projects is impressive. It has been said that timing is everything. While the operational pressures from […]

Deborah Pinchev

Using Medical Device Symbols

Key updates in ISO 15223-1:2021 Symbols are a universal language. When looking at smiley and sad faced emojis anyone from around the world can differentiate the meaning between the two. That is the power of symbols. In the right context symbols can convey a significant amount of information in a small amount of printed or […]

Nigel Syrotuck

RoHS 2 vs RoHS 3 impact on medical devices

Note: RoHS 3 is a colloquial term referring to Delegated Directive (EU) 2015/863, which is actually an amendment to RoHS 2 (Directive 2011/65/EU) rather than a standalone Directive. Though this terminology has become somewhat common (common enough to keep using the term here), it’s technically inaccurate. Originally published in April 2016, the article is updated […]

Astero StarFish

Our Top 10 medical device development videos in 2020

Our top 2020 medical device development videos include 6 new videos. They join favorites from previous years and cover subjects including 2020 updates, COVID implications for research and POC devices, optimizing founder value, manufacturing for NPI, IVD insights, and working at StarFish.

Astero StarFish

What’s the worst mistake you can make when developing a medical device?

How many have you made? We posed the question, “What’s the worst mistake you can make when developing a medical device?” to our team of engineering, design, quality, regulatory and manufacturing experts. The answers were fast and furious (well, filled with enthusiasm) and in no particular order of importance, May you read and learn from […]

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 […]

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