In Focus: Risks and Rewards

| 01 September 2011

The September issue of Regulatory Focus considers various systems used to assess and manage the risks and potential hazards associated with developing medical products. Monitoring risk is an essential component in both the medical device and drug development arenas. Medical device and pharmaceutical companies need to have appropriate programs in place to evaluate potential risks associated with their products as well as mechanisms (e.g., inquiries, complaints, market studies, focus groups, servicing) to capture customer feedback regarding product use.


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