4 Reasons Your Risk Management Approach is Wrong
Risk Management is the single most important topic impacting the medical device industry today.
Tag Archives: risk management
What Are Complaints and How Does FDA Handle Them?
CDRH’s Carl Fischer shares the agency’s approach to organizing and managing complaints.
Considerations When Using Postmarket Data in Risk Management
A review of how to incorporate complaint handling and risk management into the postmarket surveillance process.
FDA Cites Failure to Assess Product Risk in Warning Letter
Comply all the time, not just when FDA announces an inspection.
The Integration of Complaint Handling and Risk Management
A review of the important aspects of risk management and post-market surveillance processes, and how to resolve common concerns.
Meshing Drug and Device Manufacturers in Risk Management
Differing approaches to risk could hamper further growth of combination products.
Hot Topics in Risk Management & Medical Devices
Roberta Goode, president & CEO of Goode Compliance International, weighs in on the latest challenges medical device manufacturers are facing in risk management at the MedTech Intelligence HHE, Risk Assessment, & Recalls Conference in Washington, DC.
Regulatory Expectations on Risk Management
Standards are never sufficient to identify all the risk and handle all the risks. Why? Because there are a lot of stakeholders, and by the time the standard is announced, it’s already outdated. That’s why risk management is the glue between standards, and it is critical to ensure that risk management is an ongoing and continuous process, explains Peter Havel, Senior Vice President and Global Head of Medical & Health Services, at TÜV SÜD.
Standards are never sufficient to identify all the risk and handle all the risks. Why? Because there are a lot of stakeholders, and by the time the standard is announced, it’s already outdated. That’s why risk management is the glue between standards, and it is critical to ensure that risk management is an ongoing and continuous process, explains Peter Havel, Senior Vice President and Global Head of Medical & Health Services, at TÜV SÜD.