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Medical device quality managers that don’t want to wind up a statistic in a future FDA report on quality deviations should dig deeply into the agency’s recently released report on inspections, Form 483s and warning letters, says Michael Gaba, a partner in the law firm Polsinelli. Read More
Australia’s Therapeutic Goods Administration released new draft guidance spelling out what steps are needed when devicemakers that have been issued conformity assessment certificates in Australia and want to make a change. Read More
The investigation involves potential false and misleading statements executives made in connection with Avinger’s January 2015 initial public offering. Read More