Tag Archives: FDA

Benchmarking Quality: Maneuvering the FDA Regulations Obstacle Course


The Quality function within Medical device & diagnostics companies is critical for ensuring that products meet the tough standards put in place at every stage of the product lifecycle. Although the tasks completed by executives are increasing in importance, the

Avoiding Risky Business: Developing Effective REMS Plans


Due to strict FDA regulations regarding the safety of products, companies are now required to develop and deploy effective Risk Evaluation & Mitigation Strategy (REMS) plans. The ultimate goal of these plans is to both protect the public and ensure