Risk Management 360

Risk Management 360: Product Classification: Products Liability Implications

In this installment of Risk Management 360, we set the stage for discussions of specific risk mitigation strategies to come. This article explores the relationship between FDA oversight of medical devices and the implications for future products liability litigation and identifies critical risk management philosophies to which device companies should adhere.

Risk Management 360: Risk Management in Clinical Trials

In this installment of Risk Management 360, we look at clinical trials. This article discusses how products liability that arises from a clinical trial can be mitigated with the right practices and when the sponsor and principle investigator are dedicated to the integrity of the trial, the safety of trial subjects, and compliance with the various laws and regulations that govern the conduct of clinical research. We take a systematic look at the parties involved in a clinical trial, where products liability exposure can arise during a trial, what mistakes company-sponsors make to create liabili

Risk Management 360: The Relationship Between Complaint Handling and Products Liability

In this installment of Risk Management 360, we evaluate the role of complaint handling in a robust products liability risk management protocol. This edition of the series takes a close look at how this important function both fulfills the Quality System Regulations (QSR) requirements and helps companies manage potential products liability exposures.

Risk Management 360: Contracting, Part I: Why Use Contracts?

In this installment of Risk Management 360 explains why contracts are so important to life sciences companies and some particular legal doctrines that make the lack of contracts perilous to doing business in this industry.

Risk Management 360: Contracting, Part II: What Should Be In Your Contract and How to Deal with Adverse Terms from the Other Side

This installment of Risk Management 360 details the most important provisions for life sciences companies to include in their contracts and how to handle contract negotiations with limited leverage.

Risk Management 360: Managing Risk Through Product Recall Preparation

In their years working with life sciences companies – large and small – Medmarc’s risk managers have evaluated numerous medical devices and pharmaceuticals as well as their manufacturing and distribution operations and FDA compliance histories. From these experiences, our team of risk managers has developed a unique perspective on this innovative and growing industry. Life sciences companies operate in a heavily regulated and litigated environment. Through studying these companies’ successes, and their missteps, the authors of this series have discerned common trends that can influence a compa