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Posts related to ‘Regulatory change + Compliance’

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November 19, 2021
Guest authors: William Troutman, Kate Findlay and Hernan Gonzalez
Spotlight: Product safety compliance across North American borders

Foreword by Jeremy Schutz, director of business development at Sedgwick: Welcome to the latest edition of spotlight. Spotlight is our way of sharing insights and perspectives from our strategic partners – lawyers, insurers, risk managers and crisi…

November 19, 2021 by Guest authors: William Troutman, Kate Findlay and Hernan Gonzalez
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
September 22, 2021
Chris Harvey
VP, crisis solution
Pet food faces increased scrutiny as regulators hold manufacturers accountable

Research [1] has shown that many people prefer the company of their pets to that of their children. So it should come as no surprise that recent pet food recalls have angered pet lovers and spurred regulators to swift action. And of course, plaintiff…

September 22, 2021 by Chris Harvey, VP, crisis solution
Blog
September 16, 2021
Eur Ing Mark Hawksworth
Global technology specialist practice group leader and executive MCL adjuster
Claim farming for damages in light of data protection laws

As new data protection laws are introduced, so are new challenges. Claim farming occurs when parties submit claims for financial gain against targets unaware of data misuse and is on the rise in the UK. After navigating hardship related to COVID-19 a…

September 16, 2021 by Eur Ing Mark Hawksworth, Global technology specialist practice group leader and executive MCL adjuster
Blog
September 13, 2021
Luke Evans
COVID-19 is still impacting recall trends across Europe

While there’s light at the end of the COVID-19 tunnel and consumers anticipate a return to normal, ‘business-as-usual’ is still a long way off, as reported in our 2021 Recall Index report. Essential reading for manufacturers and retailers seeking i…

September 13, 2021 by Luke Evans
Blog
September 10, 2021
Chris Harvey, VP crisis solution
Stricter regulatory enforcement ahead for all industries in 2021 and 2022

As regulators, businesses and organizations emerge from the global pandemic, each is struggling to find its path to a new “new normal.” Most are finding it’s a rocky path. Significant questions and uncertainty persist, and reputational risks to compa…

September 10, 2021 by Chris Harvey, VP crisis solution
Blog
July 19, 2021
Chris Harvey
VP, crisis solution
CBD and cannabis: With opportunity comes risk

An exclusive life sciences webinar hosted recently by Sedgwick’s brand protection experts offered insight into the latest product safety challenges facing medical device, pharmaceutical and life sciences companies, including an insightful discussion …

July 19, 2021 by Chris Harvey, VP, crisis solution
Blog
July 13, 2021
Mark Buckingham
Recall advisor
Beware of all that glitters – it could be cadmium

Thanks to the ubiquity of ecommerce, consumers can now buy low-cost jewellery from anywhere in the world, but this is raising serious questions about the integrity and safety of the products, particularly the presence of potentially dangerous heavy m…

July 13, 2021 by Mark Buckingham, Recall advisor
Blog
July 09, 2021
Mark Buckingham
Recall advisor
Can new techniques help fight olive oil fraudsters?

Premium pricing and high consumer demand for extra virgin olive oil (EVOO) has long made it a target for criminals seeking to profit by passing off inferior or fake products. In fact it is now one of the world’s most adulterated food products with fr…

July 09, 2021 by Mark Buckingham, Recall advisor
Blog
July 02, 2021
Guest author: Erik K. Swanholt
Spotlight: CPSC takes first step to expand enforcement

Foreword by Jeremy Schutz, senior corporate sales manager at Sedgwick: Welcome to the latest edition of spotlight. Spotlight is our way of sharing insights and perspectives from our strategic partners – lawyers, insurers, risk managers and crisis co…

July 02, 2021 by Guest author: Erik K. Swanholt
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 18, 2021
Luke Evans
Green light for self-drive in UK raises risk concerns in motor supply chain

The UK is the first country in the world to announce regulated guidelines for self-driving cars on motorways. This means you could see cars with Automated Lane Keeping Systems (ALKS) on British roads by the end of 2021. Many cars already incorporate…

June 18, 2021 by Luke Evans
Blog
June 04, 2021
Mark Buckingham
The hidden danger in common crops

You can’t see, taste or smell them but aflatoxins can be present in everyday dried staples. And with COVID-19 and global warming impacting crop production and storage, they are on the rise. During the month of April 2021, there were 22 RASFF (Rapid…

June 04, 2021 by Mark Buckingham
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
May 14, 2021
Guest author: Carolyn Wagner
Spotlight: New proposed legislation to prevent furniture tip over

Foreword by Jeremy Schutz, senior corporate sales manager at Sedgwick: Welcome to the latest edition of spotlight. This month, Carolyn W. Wagner at Crowell & Moring LLP shares her thoughts and opinions on the STURDY (Stop Tip-overs of Unstable, Risk…

May 14, 2021 by Guest author: Carolyn Wagner
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