Publications
2025 Supply Chain Challenges for the Life Sciences Industry
The lifesciences supply chain is under pressure. In 2025, manufacturers and logistics leaders face a volatile mix of global disruptions, tighter regulations, and rapid digital change.From...
Risk Management 360: Contracting, Part II: What Should Be In Your Contract and How to Deal with Adverse Terms from the Other Side
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...
Risk Management 360: Contracting, Part I: Why Use Contracts?
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...
What You Need to Know About Products Liability Litigation: Key Takeaways
Products liability litigation has several unique facets when life sciences products are involved. Having explored several areas in which this is particularly true—case resolution, crisis...
Risk Management Checklist for Safety Information for Home-Use Products
Home-use products have been increasingly utilized by patients to improve their quality of life and to allow them greater independence. The increase in demand for home-use devices has been attributed...
Risk Management 360: Risk Management in Clinical Trials
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...
Employee Participants In Clinical Trials
Using employees as participants in a clinical trial is one solution for keeping trials on schedule. However, their participation and recruitment is fraught with the potential for inappropriate...
Product Traceability and Recall Procedures
Question: Product recall can be a serious challenge for manufacturers. What should a manufacturer do to ensure product traceability and what procedures should a manufacturer follow to...
The CMO Landscape: Diversifying to Meet an Evolving Industry
The CMO Landscape: Diversifying to Meet an Evolving Industry Part one of a three-part series on the Contract Development and Manufacturing industry and potential products liability and...
CMO FDA Regulation: Are CMOs Regulated by the FDA?
Are CMOs Regulated by the FDA? Part two of a three-part series on the Contract Development and Manufacturing industry and potential products liability and manufacturers E&O risks. Medical...