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Devicemakers up for routine postmarket surveillance audits in Malaysia will get at least two weeks’ notice, the country’s Medical Device Authority says. Read More
The Indian government is developing a medical device postmarket surveillance system, following a series of high-profile incidents in which faulty products harmed patients. Read More
The FDA handed Encompas Unlimited a warning letter for failures in quality control, implementation of medical device reporting procedures and incomplete device history records.
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Devicemakers can improve their facility inspection experience by engaging in constructive conversations with agency investigators, an FDA official says. Read More
Swiss and Chinese regulators plan to harmonize their regulations on market authorization and postmarket surveillance, with the aim of speeding access to new products in both markets. Read More
The FDA has warned Craftmatic Industries over inadequate complaint handling and manufacturing procedures for its Adjustable Home-Use Therapeutic Bed. Read More
Life Technologies, a manufacturer of biomedical products, was handed a Form 483 for failing to submit timely MDRs after erroneous results from some of its tissue-typing kits. Read More
Device failures and inadequate complaint handling procedures resulted in a Form 483 for Biogenex Laboratories, a maker of automated molecular pathology workstations. Read More