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June 28, 2022
Chris Occleshaw
recall consultant
European recalls decline 2.4% overall in the first quarter of 2022

Even as many countries eased pandemic-related restrictions, recent events have introduced a new host of challenges and risks for the five key industries surveyed in our latest edition of the European Recall Index report. Our report includes analysis …

June 28, 2022 by Chris Occleshaw, recall consultant
Blog
March 24, 2022
Chris Harvey
VP, crisis solution
FDA urges companies to be ‘recall ready’ as it releases finalized guidance

The U.S. Food and Drug Administration (FDA) recently finalized a guidance document outlining how companies and stakeholders should become “recall ready” to minimize buyers’ and users’ exposure to potential health risks.The Initiation of Voluntary Rec…

March 24, 2022 by Chris Harvey, VP, crisis solution
Blog
March 11, 2022
Julie Ross, International business development director and Luke Evans, business development manager
European recalls rose in 2021 despite COVID-19 disruptions

As we enter the third calendar year of the COVID-19 pandemic, regulators are adapting to the “new normal.” As reported in our latest edition of the recall index report, product recalls rose by over a quarter (25.5%) across key European industries in …

March 11, 2022 by Julie Ross, International business development director and Luke Evans, business development manager
Blog
March 04, 2022
Chris Harvey
VP, crisis solution
Recall index sees lingering COVID-19 challenges for all key industries in 2022

While regulators and business leaders enter the third calendar year of COVID-19, some new challenges are emerging atop the lingering supply chain and service issues brought on by the pandemic. The Biden administration continues to push for more consu…

March 04, 2022 by Chris Harvey, VP, crisis solution
Blog
February 11, 2022
Matt Walker
recall advisor
FDA focuses on women’s health in medical device research and regulation

The US Food and Drug Administration (FDA) has turned its attention to the development and regulation of medical devices unique to women’s health. The FDA’s Center for Devices and Radiological Health (CDRH) recently finalized its Health of Women…

February 11, 2022 by Matt Walker, recall advisor
Blog
December 17, 2021
Matt Walker
recall advisor
New threat modeling playbook prepares medical devices for cybersecurity issues

Cybersecurity has become a critical issue for the medical device industry, where a cyber threat can lead to injury or even death. To address this growing problem, the U.S. Food and Drug Administration, the MITRE Corporation, and the Medical Device In…

December 17, 2021 by Matt Walker, recall advisor
Blog
December 13, 2021
Chris Harvey
VP, crisis solution
Regulatory, legal and reputational risks increasing for all businesses in 2022

We are living through a perfect storm of heightened business risks that are impacting every industry — from labor shortages, supply chain issues and inflation to increased regulatory oversight and enforcement. When combined, these risks pose su…

December 13, 2021 by Chris Harvey, VP, crisis solution
Blog
December 08, 2021
Julie Ross
International business development director
Q3 2021 recalls signal a return to pre-pandemic levels

As we emerge from one of the most turbulent and uncertain times in recent history, consumers are eager for a return to normal and economists are predicting a boom as we approach the holiday season. But with so much uncertainty still ahead, it seems t…

December 08, 2021 by Julie Ross, International business development director
Blog
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
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