Publications
Risk Management
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...
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...
Insurance Considerations for Global Clinical Trials
Excerpted from the Journal for Clinical Studies, September 2009. As the number of trials being conducted in multiple countries continues to increase, sponsors must insure themselves against...
The Biomaterials Access Assurance Act
Abstract: A life sciences broker recently contacted Medmarc regarding a company that was interested in expanding into the medical device supply market. The company was under the mistaken...
IMDA: Together We're Better
Being the owner of a small, entrepreneurial company can be exhilarating. You write your own ticket, set your own direction. But it can also be daunting. After all, there are no corporate coffers...
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...
Litigation for Life Science Companies: Aspects of Litigation That Should Affect How You Run Your Business
The prior twelve articles in this series have focused on products liability in general and the various aspects of designing, making, and selling medical devices. These articles pointed...
Supplier Controls
Medical device manufactures often use component parts provided by a supplier to complete a finished medical device. Manufacturers should be concerned with the reliability of supplier...