The International Organization for Standardization (ISO) has strengthened benefit-risk language in the latest redo of ISO 14971, the voluntary standard that instructs device-makers on how to best put together a risk management program. Regulators – including US FDA – are increasingly considering benefit-risk when weighing product availability and regulatory compliance issues. And Jos Van Vroonhoven, convener of a joint working group that revised the standard, says a more global regulatory emphasis on risk management and a desire to clarify the document in general led ISO to revise the standard. Also: Van Vroonhoven identifies four updated clauses in the revamped standard that firms should keep a sharp eye on.
More regulators worldwide are considering the benefits of flawed medical devices when deciding whether they should remain on the market. In response, the International Organization for Standardization (ISO) has strengthened benefit-risk language in the latest revision of its voluntary risk management standard.
That standard, ISO 14971, instructs device-makers on how to best put together a risk management program; it was originally released...
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