The FDA Agile Practices In Medical Device Development Under IEC 62304

Agile methods are state-of-the-art for software developers and they can be adapted to IEC62304 in the highly regulated medical device field. The Association for the Advancement of Medical Instrumentation (AAMI) has issued a Technical Information Report, TIR45 Guidance on the use of AGILE practices in the development of medical device software

The FDA Applies Recommendations To Mobile Medical Applications

The use of Smart Phones to deliver and medical services to patients and their caregivers is becoming more and more ubiquitous.

The FDA, Cybersecurity and Coexistence for Bluetooth and Wi-Fi Enabled Devices

Integrating wireless technology into medical devices has numerous benefits that positively impact patient outcomes both by allowing caregivers real time access to patient data and by providing the ability to remotely program these devices.

Quicker Proof of Concept and Prototyping

Commercial product development using low cost computing platforms like the Raspberry Pi, the Arduino and the Odroid is on the rise.

Current Design Includes An Explosion of Blue Tooth LE (BLE) Applications

There has been an explosion of awesome BLE applications for games, sporting goods, medical devices, sensors, wire replacement and more. BLE transmits less data over shorter distances using much less power than Bluetooth.

Increasing Efficiency in Developing a Higher Quality Product

There are many advantages to using a Software Framework, the most important being the re-use of code that has been tested, thereby reducing programming and testing labor and time to market.

Enhancing Your Risk Management Process

Medical device companies are required to implement risk management processes in compliance with ISO 14971.