Posts categorized as“Regulatory”

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The US Food and Drug Administration (FDA) published a draft guidance document in December 2021 outlining transition plans for medical devices currently marketed under Emergency Use Authorizations (EUAs) during the COVID-19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 […]

Astero StarFish

Our 10 most read medical device commercialization blogs of 2021

Two new medical device commercialization blogs, one returning champion, and two new authors join our 2021 “most read” list. Electrical engineering amd regulatory articles tie for the most popular blog topics. Many thanks to our employee authors past and present for sharing their insights and experience with medical device colleagues.

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 […]

Azra Rajwani

Returning to Work Safely During COVID

I think it’s safe to say that returning to work is going to look very different in a post-pandemic life. Or what we are now calling the ‘new normal’. Many of us are now used to working in our pajamas and rolling right out of bed into our desk, but we will eventually have to […]

Alexandra Reid

Pathways to a FDA Approved or Cleared Medical Device

Chutes and Ladders – Commercializing your medical device in the US market requires submitting marketing applications to the FDA to become an FDA Approved or Cleared Medical Device. The content of your FDA submission is determined by how your medical device is classified into one of three Classes (I, II, or II), based on the […]

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 […]

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