Posts categorized as“Quality”

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 […]

Vesna Janic

When do you need a Quality Management System (QMS)?

“When do I need a Quality Management System (QMS)?” is the most common question that we get asked by new clients who are just entering into the medical device field. The answer depends on your target market and your exit strategy. To be frank, it is somewhat a chicken and egg thing.

Henry Ho

First-to-Market strategy, trade-offs and tips for medical devices

In a previous medical device company, I worked on a project where First-to-Market (FTM) was a deemed a priority for the company’s survival.  To meet that highly compressed timeline, we decided to skip the phase-gate process and replace it with a FTM production release strategy. FTM product commercialization carries a much higher overall project risk […]

Sam Fox

Proper documentation pays big dividends for visiting entrepreneur

When I arrived at StarFish with my idea for a patient handling device, I had just completed my engineering degree and was searching for further education in medical device development. Fortunately for me, StarFish provided master-level classes (albeit unaccredited) in project management, including Dealing with Vendors 101: Expect Delays and QMS 201: How to Maintain […]

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