With recent requirements, the FDA is taking a hard stance: cybersecurity is a core consideration with compliance being ...
Several rules and regulations have important due dates in 2025 and beyond for which medical device manufacturers should be ...
Quality Management Systems (QMS) are integral for medical device manufacturers as they ensure adherence to regulations and help in producing top-quality products. Utilizing the right QMS software ...
Venudhar Rao Hajari has built a successful career in the areas of Medical Device Development Quality Assurance, Software ...
On December 4, 2024, the U.S. Food and Drug Administration (“FDA”) released its final guidance for industry on predetermined change control ...
Guardpack, a UK-based contract manufacturer of wet wipes and sachets, has secured funding that enables expansion into the ...