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.
Read MoreAchieving 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.
Read More