Registration to IEC 62304
Embracing new technology innovations is of prime importance for creating and maintaining product competency. Medical devices companies are leading such innovations with the adoption of technology trends like miniaturization, portability, enhanced connectivity and reliability.
Machine-to-machine communication enabled due to different connectivity options like Wi-Fi, NFC form the basis of Internet of Medical things which can be then linked to the cloud platform, on which captured data can be stored and analyzed.
Pharmaceutical companies are also embarking on this innovative development for better drug delivery and home care.
BBT has hands-on engineering experience in FDA Class 2 and Class 3 devices for monitoring, diagnostics & imaging, wearable health and telemedicine.
We provide HIPAA compliant engineering solutions, and have the required process expertise in IEC 60601-1/2/6, IEC 62304, 510K and ISO 13485.
Mark Cain got his big break on June 9, 2008. The chief technology officer at a little-known medical software company, MIM Software, Cain was invited onstage at Apple’s Worldwide Developer Conference to promote his company’s iPhone app, a way for doctors to view incredibly detailed scans of their patients...