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Verathon Medical ended an FDA inspection with a Form 483 for implementing changes to processes before appropriate verification and validation. Read More
Viramed Biotech, a German manufacturer of in vitro diagnostics, received a one-observation Form 483 related to an issue with its quality control procedure. Read More
The FDA slapped Sollentuna, Sweden-based MKL Diagnostics with a warning letter for failing to have a design control procedure for its Phadebact test kits. Read More
Cook Medical is under pressure from the FDA to fix sweeping quality problems at its Indiana facility relating to how the devicemaker addressed more than 735,000 manufacturing nonconformances over a two-year period. Read More
Using QSIT for internal audits could put devicemakers in a much stronger position when FDA investigators coming knocking on the door, compliance experts agree. Read More
Devicemakers have a better shot at emerging from an FDA inspection unscathed if they watch for common investigator tactics, such as stepping away from the company contact, an expert says. Read More
Medtronic cleared the final regulatory hurdles ahead of its planned $43 billion merger with Covidien, getting a positive nod from antitrust bodies in China and South Korea. Read More
Medical software that allows caregivers to noninvasively evaluate blood flow in patients with coronary artery disease gained marketing clearance from the FDA late last month. Read More
The Brazilian government is providing more clarity around a voluntary program that encourages public-private partnerships to expand access to affordable medical devices and diagnostics, but questions remain about the program’s transparency. Read More
Greiner Bio One Brasil Produtos ran afoul of the FDA after documenting design changes in informal meetings with informal notes, a recent warning letter shows. Read More