How does the changing landscape of international standards overlap with design control, and how should devicemakers account for these changes in their risk management plans? Source: The GMP Letter

As of June 1, South Africa has its first regulatory system for medical devices and in vitro diagnostics, which will include new quality management requirements. Source: The GMP Letter

Following a spate of superbug outbreaks and deaths from contaminated duodenoscopes and similar devices, the FDA will soon have tougher validation requirements for certain new devices. Source: The GMP Letter

Companies most likely to benefit from the Medical Device Single Audit Program will include those selling products in Canada, along with manufacturers of finished medical devices and high-risk devices, said…

The FDA issued warnings to three device manufacturers for failures in GMPs, validations, MDRs, and other quality-related issues. Source: The GMP Letter

Repro-Med Systems in Chester, N.Y. failed to submit a report to the FDA on steps taken to reduce a health risk posed from a device, inspectors found during a late…

Some devicemakers can be slow to recognize trends in medical device complaints. It’s not enough to have a solid complaint handling system when regulators expect you to learn something from…

CDRH and the Office of Regulatory Affairs would have to “reprioritize and reevaluate” device programs under the Trump administration’s proposed budget for fiscal 2018. Source: The GMP Letter

Australia’s Therapeutic Goods Administration will likely follow the FDA’s lead and the International Medical Device Regulators Forum’s model for regulating software for medical devices. Source: The GMP Letter

Two-thirds of medical devicemakers and about half of healthcare delivery organizations believe a cyber attack on a medical device built or in use by their organizations is likely to occur…