Posts by Deborah Pinchev

Deborah Pinchev

UK Medical Device Brexit Implications

On June 26, 2022, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released the Government response to consultation on the future regulation of medical devices in the United Kingdom. This response will effectively guide the UK’s post-Brexit implementation plan for medical device regulation. The following are high-level key points that are sure to be […]

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 […]

Deborah Pinchev

COVID-19 Testing Authorizations in the US and Canada

This blog provides an overview of COVID-19 testing authorizations and developments of the COVID-19 pandemic in the United States and Canada. In the world of regulated health care products these tests are known as in vitro diagnostics (IVDs) and fall under the medical device definition in most jurisdictions. Almost 6 months since both the FDA […]

Join over 6000 medical device professionals who receive our engineering, regulatory and commercialization insights and tips every month.

Website Survey

Please answer a few questions about our website.

Take Survey No Thanks