Posts categorized as“Uncategorized”

Ryan Field

Spectrometer from home materials

Make a real-time, wavelength-calibrated spectrometer using common household items. Like many others, I’m currently working from home due to the ongoing COVID-19 crisis. Fortunately, a significant portion of my optical engineering work, such as research, modelling and design, can be done without going into the office. On the other hand, I generally avoid going into […]

Astero StarFish

Optics handling during manufacturing

Our Optics experts and manufacturing leaders met to identify lessons learned and tips from recent projects involving optics handling during manufacturing, prototyping and transfer to manufacturing. This blog features their tips and lessons for handling optics during the manufacturing process.      

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’.

Laura Gouzecky

How ERP Benefits Medical Device Commercialization

I’m often asked how ERP benefits medical device commercialization. Enterprise resource planning (ERP) is a very powerful tool that helps many companies succeed.  The medical device industry faces unique challenges from FDA and CFR requirements, regulations, and standards. These challenges mean that ERP can aid medical device commercialization even more than other industries and products.

Dana Trousil

First-to-Market Vs. robust commercialization: trade-offs, tips, and tactics

Bringing your medical device to market involves a lot of trade-offs. First-to-Market Vs. robust commercialization process. Do you launch quickly with a minimum viable product? There may be significant post-launch changes in order to be the first to market. Possible negative feedback from rushing to market may destroy any device adoption. Perhaps going through an […]

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