ISO 10993-1:2025—Biological Evaluation of Medical Devices
Medical devices range from simple bandages to complex implantable devices like pacemakers and prosthetics. Regardless of their complexity, all medical devices must undergo rigorous testing…
ANSI/AAMI HE75:2025—Medical Device Design
Medical devices are essential to modern healthcare, but their safety and effectiveness rely heavily on human factors engineering (HFE). HFE helps reduce use errors (a…
Why Is ISO 9001 the Universal Standard?
ISO 9001 is a globally recognized and widely adopted standard for Quality Management Systems (QMS)—a formalized system that defines and documents an organization’s processes, procedures,…
Why You Need a Business Plan—and How to Create One
71% of fast-growing companies have a formal business plan, and businesses with a business plan are 260% more likely to launch and 30% more likely…
IPC-1792, Cybersecurity in Electronics Manufacturing
Due to the interconnectedness and digitization of manufacturing processes, cybersecurity issues in the electronics manufacturing supply chain are becoming more numerous and evolving. Weaknesses in…
The Future of Jobs: How AI is Reshaping Work as We Know It
Artificial intelligence (AI) is predicted to affect almost 40% of jobs around the world, replacing some and complementing others. Consequently, we need a careful balance…
ANSI Compliance Connect: Enhance Your Compliance Management
ANSI Compliance Connect is a cloud-based service designed to streamline compliance management. Compliance management is the continuous process of monitoring and assessing systems to assure…
ISO 10377:2013— Consumer Product Safety
According to the Consumer Product Safety Commission (CPSC), in 2020, an estimated 28.5 million people sought medical attention for consumer product-related injuries in the United States,…
INCITS/ISO/IEC 27102:2019 (2020)–Cyber-Insurance
In the first half of 2024, the frequency and value of large cyber insurance claims increased by 14% and 17%, respectively, compared to 2023; according…