Risk Management is the systematic application of management policies, procedures and practices in the tasks of analysing, evaluating, controlling and monitoring risk. It is applicable for both Pharmaceutical and Medical Device industries.
Your product must be built with risk management in mind from the moment of conception until the termination of the product, to ensure safe and effective products of good quality. Safety = freedom from unacceptable risk. [Note: No medical device pharmaceutical is free from risk] Risk Management is good business practice, helps to reduce the need for costly and time consuming changes to designs or processes etc., is a regulatory requirement for manufacturers of medical devices and healthcare products, and is part of Design Validation.
We can assist in the entire process of Risk Management – Hazard Analysis and completion of Risk Management Report.