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Posts related to ‘Medical devices’

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September 28, 2021
Matt Walker
FDA regulations for AI/ML-based medical devices expected soon on heels of EU MDR

Following the lead of the European Union and Great Britain, the U.S. FDA has begun rolling out its action plan for regulating artificial intelligence/machine learning (AI/ML)-based software as a medical device. The United Kingdom’s Medicines and He…

September 28, 2021 by Matt Walker
Blog
June 22, 2021
Chris Harvey
VP, crisis solution
Expect regulatory scrutiny and product recalls to soar after COVID pandemic

As the post-COVID-19 world begins to reopen, we’re starting to find our way back to normalcy. But regardless of how quickly the entire country returns to "business as usual", risks to brand reputations are likely to increase as regulators resume work…

June 22, 2021 by Chris Harvey, VP, crisis solution
Blog
June 02, 2021
Matt Walker
recall advisor
DOJ increasing enforcement on off-label promotion: Here’s what to expect

We’ve been warned. Recent settlements between the U.S. Department of Justice (DOJ) and several FDA-regulated drug and medical device manufacturers serve as a prelude to future DOJ enforcement activity involving off-label promotion. The DOJ and the U…

June 02, 2021 by Matt Walker, recall advisor
Blog
December 31, 2020
Global perspective on pharma and medical device recalls during the COVID-19 crisis

The global response to the coronavirus crisis put a bright spotlight on the complexity of global supply chains. But not only in the traditional, “behind-the-scenes” way we think about companies sourcing inputs, component parts and ingredients. It als…

December 31, 2020
Blog
July 13, 2020
Medical Device Regulation Extension and Recalls

The Medicines and Healthcare products Regulatory Agency (MHRA) leads the charge on assuring the safety of medicines, medical devices and blood components for transfusion in the UK. Its core job is to ensure the products meet applicable standards of s…

July 13, 2020
Blog
April 24, 2020
Personal protective equipment in the spotlight as countries battle COVID-19

The COVID-19 pandemic has resulted in an unprecedented, global demand for personal protective equipment (PPE), with several countries placing export bans on the sale of PPE and costs increasing by up to 1000%. In the past month, alerts for PPE pla…

April 24, 2020
Blog
April 21, 2020
Medical devices in the spotlight as countries battle COVID-19

Across the globe, nations are doing whatever they can in the fight against the COVID-19 pandemic. And while different strategies are being used in different countries, the use of medical devices to combat the virus is well-known with ventilators, med…

April 21, 2020
Blog
March 27, 2020
Professional Liability Team, Sedgwick
Are you prepared? Healthcare and liability concerns during the coronavirus outbreak

As a claims organization, it’s up to us to keep our clients and their customers informed on current issues and deliver peace of mind. The healthcare, product liability and life sciences space is constantly evolving, but we’re keeping an eye on the fo…

March 27, 2020 by Professional Liability Team, Sedgwick
Blog
May 21, 2019
Drop in medical device recalls to be welcomed

Of all product recalls, the one people least look forward to is a recall of medical devices — which is why a year-on-year reduction in recalls, no matter how small, is to be welcomed. Between the beginning of 2019 and 3 May, just 27 recalls w…

May 21, 2019
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