saanvi shing

Certainly. In the realm of medical device regulatory compliance, effective risk management is paramount to ensuring patient safety and product quality. As an Medical Device Regulatory Consultant my approach to risk management involves several key steps:
Risk Assessment: I begin by conducting a comprehensive assessment of potential risks associated with the medical device, considering factors such as device complexity, intended use, and patient population.
Regulatory Analysis: I closely examine relevant regulatory requirements, including those set forth by the FDA and international regulatory bodies, to identify specific compliance obligations related to risk management.
Hazard Identification: I work with clients to identify potential hazards and failure modes associated with the medical device throughout its lifecycle, from design and development to manufacturing and distribution.
Risk Control Measures: I collaborate with clients to develop and implement risk control measures aimed at