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Medical device and drug manufacturers are increasingly doing business with foreign suppliers to locate comparatively inexpensive raw ingredients and component parts...
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Contracts are an essential part of most business relationships, yet life sciences companies frequently fail to contract with important business partners, such as suppliers and distributors.... Learn More »
Webinar|Slides
Design defects often give rise to costly products liability claims. This webinar will discuss the impact that design controls can have on products liability claims and why design controls matter to the FDA. ... Learn More »
Sales reps who enter clinical settings, such as operating rooms, often provide invaluable information to medical professionals, yet their presence is fraught with liability perils. ... Learn More »
Learn what the life sciences industry should expect from the Food and Drug Administration (FDA) in 2012. This webinar will review the regulatory issues and enforcement trends that may impact your operations and bottom line. ... Learn More »
The medical device landscape is constantly changing as new science and technologies emerge. As the technology changes, so does the potential for liability and lawsuits surrounding the technology. ... Learn More »
This webinar features Medmarc’s Chief Claims Officer, Cynthia Khin, and Attorney Joseph Thomas, whose practice focuses on the life sciences industry and was involved in the recent Supreme Court case, Pliva, Inc. v. Mensing.
Companies may not be aware that additional post-market activities not mandated by the FDA may be necessary to mitigate products liability exposures.... Learn More »
Slides
Life sciences companies that wish to avoid FDA enforcement actions must be able to respond effectively to FDA-483s and Warning Letters.... Learn More »
This webinar will provide an overview of key products liability concepts relevant to life sciences distributors.... Learn More »
As many life sciences companies work to innovate and bring their inventions to the commercial market, the challenge of managing business operations risk often gets added to the responsibilities of CFOs, human resources managers, and compliance office... Learn More »
This page contains general information on recalls, including best practices, tips for working with FDA and other regulatory entities, and brand protection.... Learn More »
Slides|Podcast
This page contains information on the FCPA. The webinar and podcast feature Carlos Ortiz, an attorney who specializes in FCPA law and compliance.... Learn More »
Learn the basics of the discovery process to be more effective in your handling of the important pre-trial litigation process.... Learn More »
This page contains information on how to properly preserve and handle products involved in adverse events.... Learn More »
Learn about changes the medical technology and life sciences industry should expect from the FDA in 2011.... Learn More »
Learn about upcoming federal legislation that may impact the medical technology and life sciences industry in 2011. The webinar and podcast feature Jeffrey J. Kimbell, a lobbyist who represents clients in the life sciences community.... Learn More »
The information on this page covers some of the most critical discovery topics facing medical technology and life sciences companies today, including strategies that have been proven to help companies reduce discovery burdens.... Learn More »
The information on this page discusses the informed consent process, including the role of the FDA and Institutional Review Boards (IRBs), pitfalls to avoid when drafting and executing informed consent documents and best practice tips.... Learn More »
This information discusses some of the industry trends and challenges associated with foreign clinical trials.... Learn More »
The resources on this page contain information on how companies are currently using social media in a manner that is compliant with FDA regulations.... Learn More »
The resources on this page will deal with "No Injury" Class Actions and Emerging Medical Monitoring Claims in depth and discuss whether exposure to a known harmful substance is sufficient, by itself, to constitute bodily injury.... Learn More »
This webinar helps financial managers/insurance buyers understand and make informed decisions about coverage, risk and premium.... Learn More »
These resources contain information on the CE mark, including what it is, how to get it and how to keep it.... Learn More »
These resources contain information about pharmacovigilance and related trends in products liability litigation.... Learn More »
These materials offer important and timely information about off-label practices, the connection between off-label promotion and products liability and techniques to avoid potential liability resulting from off-label promotion.... Learn More »
Webinar|Slides|Podcast
Medmarc’s Loss Control Team has developed a set of resources that offer information about the products liability risks associated with warnings and instructions and the techniques you can use to minimize those risks.... Learn More »
Who are non-manufacturer sellers-distributors and how are they set up? Why does the plaintiff sue the non-manufacturer sellers when non-manufacturer sellers do not make the product?... Learn More »
This information can help your sales force avoid inadvertently creating grounds for products liability claims.... Learn More »