Establishing and Maintaining the Device History Record
The Device History Record is the proof that the product was manufactured in accordance with the DMR. The DHR can easily be tailored to a device manufacturer’s specific needs
The Design History File (DHF) is a compilation of documents that demonstrates that a logical and controlled process was followed during development of a particular medical device.
The Restriction of Hazardous Substances Directive (RoHS) is a European Union directive restricting the use of specific substances considered hazardous to the environment in certain electronic and electrical equipment.
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.
According to Intertek, 50% of products fail EMC testing the first time, with Medical Devices slightly more successful with a 40% failure rate. By the second round, success is 93% to 97%. How can manufacturers increase chances of passing EMC testing the first time?
Using the IEC 62304 Standard to Improve Your Software
Medical software and devices that utilize software now require compliance to IEC 62304. This includes not only devices that require compliance to IEC 60601-1 but also 61010-1 safety standards, and devices which require FDA pre market submissions.
