Audits Simplified!
June 23, 2025
Customer audits are a critical aspect of maintaining and improving the quality of your products and services. Successfully navigating these audits can enhance organizational reputation, build trust with clients, and ensure compliance with industry standards.
June 23, 2025
The European Union has established comprehensive regulations for the use of artificial intelligence (AI) in medical devices through the Artificial Intelligence Act (AIA). This Act aims to promote the development and use of "human-centric and trustworthy" AI in medical devices and in vitro diagnostic devices (IVDs).
June 23, 2025
Internal auditing is a critical component in the medical device industry, ensuring that companies comply with regulatory standards and maintain high-quality products. This process involves systematic examination of various aspects of the company's operations, from design and manufacturing to distribution and post-market surveillance.
June 23, 2025
How a medical device company with limited resources is leveraging Ai.DIT™ to address Quality System gaps and updating their Quality system to meet FDA Quality Management System Requirements (QMSR), making the organization compliant to 21 CFR 820 regulation.