Posts categorized as“Western Region”

Thor Tronrud

Tips to Avoid Medical Device AI Pitfalls

Roughly 80% of human brain volume is made up by the neocortex, a set of highly interconnected layers of neurons that controls our higher brain functions, such as perception, cognition, motor control, and language. This massively parallel architecture is the initial inspiration for Deep Learning – a neural network paradigm that excels at pattern recognition […]

Alexandra Reid

Preparing EUA Medical Devices for Post-Pandemic Use

The US Food and Drug Administration (FDA) published a draft guidance document in December 2021 outlining transition plans for medical devices currently marketed under Emergency Use Authorizations (EUAs) during the COVID-19 public health emergency (PHE). The FDA has issued EUAs for a vast array of medical devices during the pandemic including ventilators, infusion pumps, personal […]

Alexandra Reid

Regulatory Science Tools Reduce Risk in New Medical Devices

The FDA’s Center for Devices and Radiological Health’s (CDRH) Office of Science and Engineering Labs (OSEL) is a part of FDA’s initiative to speed up medical device development and patient access to safe and effective medical devices by producing tools using innovative science in the assessment of new medical devices. A Catalog of Regulatory Science […]

Nigel Syrotuck

How to Conduct Particulate Pre-Testing for ISO 18562-2:2017

Recently we conducted pre-testing (testing done in-house to increase confidence before undertaking more expensive formal testing) for ISO 18562-2:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 2: Tests for emissions of particulate matter is an ISO standard for particulate testing in breathing gas pathways. This is a sub-standard of the larger […]

Nigel Syrotuck

How to Perform Medical Device Drop Test

Medical Device Drop Test Per IEC 60601-1 Ed 3.2 Clause 15.3.4 Medical Device Drop Test and Push Test are part of IEC 60601-1. This blog describes two of the most common mechanical tests that medical device designers may want to perform in-house before sending a device for third party testing.

Aaron Philippsen

Three Physical Connection Methods in Medical Device Test Fixtures

Physical testing is an essential tool for product development, particularly when developing a novel medical device. When well designed, a physical test can accurately represent phenomena that are difficult to model, and physical tests can often be constructed quickly with a minimum of custom components. Here are three connection methods that I have found useful […]

Megan Griffin

Five Considerations for Successful Onboarding

Ensuring new hires feel connected to the team and engaged in their position is critical. So much has changed since moving to remote work, including the onboarding process. Don’t be fooled; the initial weeks or months aren’t just when an organization assesses their new hire, it’s also for the new employee to determine if they […]

Nick Allan

Biotech in medical device companies

3 compelling reasons to pursue a Bio Services career in medical devices 2020 highlighted the need for Biotech in medical devices and shone a light on potential careers in this field.  The global CoVID-19 pandemic developed and grew over 2020 from the initial focus on traditional medical device development to rapid development and manufacture of […]

Tammy Dewar

Is there job growth potential?

Don’t underestimate the value of leadership development Employers who question the value of training often ask “What if we train people and they leave?” As a leadership development facilitator and coach, I often respond, “What if you don’t train people and they stay?” I’ve spent literally thousands of dollars investing in my own development, and […]

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