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Connected drug delivery devices integrate digital connectivity — often via Bluetooth — with traditional drug administration ...
Every new medical device feature must live within a quality management system that tracks design control, risk management, ...
The FDA proposed on Feb. 22, 2022, an update to the Quality System Regulation 1 that was released in 1996. The proposal is to reference ISO 13485:2016 Medical devices — Quality management systems — ...
Cardiovascular diseases are responsible for over 15 million deaths worldwide per year. 1 The occlusion of vessels such as the coronary or peripheral arteries hinders the flow of blood to the heart, ...
The digital revolution that resulted in the Internet of Things (IoT), Internet of Medical Things (IoMT), Software as a Medical Device (SaMD), and connected devices permeating the healthcare ...
Periodically, standards are revisited by international and national committees to determine if they are still current or need revision or withdrawal. Through the voting process and based on comments ...
Product labels that appear on device packages, admittedly, are not the most exciting part of medical device product design and development. They lack the excitement of scientific discovery, the cachet ...
Throughout this series, I have focused on plastic parts used in your medical device and the associated mold production process. I began with the fundamentals needed to define and design a plastic part ...
Regulatory oversight and scrutiny of health technology (healthtech) companies has emerged as a priority for the federal government. Charged with mitigating fraud and abuse, protecting consumers, and ...
How a medical product is perceived enables usability and has scientific premises in human factors/usability engineering (UE) and industrial design. Each discipline shares theories that, when ...
There was a time when the inbound supply chain was perceived as a back-end operation, where no news was good news. Today, when supply chains are expected to provide real customer value, there are some ...