A Strong Post-Market Surveillance Enables a Strong Risk Management System

The concept of risk-management is not new to Medical Device companies. The challenge, however is to consistently apply risk-management principles throughout the entire product lifecycle. A strong post-market surveillance process is key to building the organizational capability of a strong and holistic risk-management system.

Customer ExperienceNaveen AgarwalMay 22, 2018Risk, ISO 14971, Post-market Surveillance, Product lifecycleComment

FDA is Using the Least Burdensome Approach. Are You?

Achieving and sustaining Regulatory Compliance is a huge resource drain for Medical Device companies. That is why it is refreshing to hear that the FDA is now renewing its focus on a least burdensome approach to all regulatory activities.

Regulatory ComplianceNaveen AgarwalDecember 28, 2017Least Burdensome, Product lifecycle, Risk Comment