We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
When undergoing an FDA inspection of a manufacturing plant, complying with agency requests and professional interactions with the investigators are the key, a panel of former FDA investigators advised during the 15th Annual FDA Inspection Summit hosted by FDAnews. Read More
Medical Device Single Audit Program (MDSAP) activities have continued during the COVID-19 pandemic, forcing auditors and device manufacturers to adapt to a virtual environment. Read More
A draft FDA guidance recommends sponsors of medical devices that are electrically powered or have electronic circuitry provide 11 categories of safety information in their premarket submissions. Read More
As part of its vast overhaul of its drugs and devices regulatory system, China has been placing a heavy emphasis on postmarket surveillance over the last two years. Read More
The FDA’s Office of Regulatory Affairs (ORA) has determined that general and prioritized inspections will remain preannounced for the foreseeable future in order to ensure the safety of those involved during the pandemic, according to a regulatory official. Read More
The EU’s implementation of the new In Vitro Medical Device Regulation (IVDR) “has ground to a halt in the wake of the COVID-19 outbreak,” MedTech Europe said, pressing the European Commission for help with the transition process for high-risk devices. Read More
Geist will focus on growing the firm’s digital biomarker measurement technology Simoa, including its neurology franchise, as well as COVID-19, infectious disease, immunology and oncology products. Read More
Steris’ chief said that Key Surgical’s “focus on the sterile processing department, operating room and endoscopy fits perfectly with our core healthcare customers.” Read More
HiRise is able to scan anywhere along a patient’s lower extremity, from the hip and pelvis to the feet, and is the first system able to conduct weight-bearing CT scans of the hip and pelvis, the company said. Read More