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As notified bodies in the EU conduct the first wave of unannounced quality audits of devicemakers, they are building profiles of the companies to determine when and how often they are inspected in the future. Read More
St. Jude Medical has resolved good manufacturing practice issues that had plagued its Plano, Texas, neuromodulation facility, leading to a 2009 warning letter. Read More
Medtronic Ireland failed to submit MDR reports within 30 days of becoming aware of an event, including two that involved the death of a patient, according to a May 15 Form 483, recently released. Read More
Terumo BCT has received a Form 483 citing manufacturing problems with incoming product acceptance and environmental controls on its blood collection systems. Read More
Devicemaker Brava, a manufacturer of breast enlargement devices, received an FDA warning letter for violating informed consent procedures and conflict-of-interest issues related to clinical trials of its fat micrografting device. Read More
The Therapeutic Goods Administration plans to obtain its own evidence on the quality of certificates and reports issued by select EU notified bodies, after a medical journal report cast doubt on the thoroughness of the reviews they were performing. Read More
The International Medical Device Regulators Forum’s single-audit pilot program is running on schedule, an FDA official working closely with the program tells IMDRM. Read More
The FDA is telling Health Science Products to get certification from an outside expert, after the company purchased components from unqualified suppliers. Read More
Devicemakers will have 13 new product-specific guides by the end of the year to tell them what quality-related metrics FDA investigators will focus on during site inspections, agency officials said Tuesday. Read More