Technical writing or technical documentation has evolved into a subject of growing significance in the world of written communication. Consider it as a natural offshoot of the knowledge-based economy, given its specialized nature, especially in the developed world. Hence, qualified technical writers are in demand in various industries, including software, telecommunications, financial services, healthcare, pharmaceuticals, and medical device manufacturing.

In Europe, the demand for medical devices has increased by many folds. While medical device manufacturers are relying on the market demand, they must also make sure how their product is considered and classified in Europe. The fact that the device is accepted in other countries like USA, Canada or Japan does not always have to be conformed to the European Device Directive (EDD). Thus, it is important for manufacturers to first decode how the devices are classified in Europe.

Heads-up: Class II Device’s Unique Device Identifier (UDI) Compliance is here. As part of the phased approach to UDIs, the US Food and Drug Authority (FDA) has mandated manufacturers of Class II devices to get complied by Sep 24 2016. The upcoming mandate is succeeding the Class III (Implanted) devices’ compliance in 2015 and preceding the Class I devices’ compliance scheduled in 2018.