Posts categorized as“Quality”

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 […]

Clara Li

Navigating Medical Device International Regulations

Bringing medical devices to market in a single country can be a regulatory challenge. The process often becomes much more complex when marketing in multiple countries and navigating medical device international regulations. A comprehensive understanding of current regulations in each country of interest is required as device laws and regulations are constantly changing. If you’re […]

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