Many medical devices companies are adding wireless functionality to their products. However, many do not realize that this adds another layer of complexity to the regulatory approval process. Not only does the device need to comply with national health regulations published to ensure patient and user safety, they must also comply with issues related to use of the wireless spectrum in a specific country.
Medical device manufacturers whose products rely on wireless and mobile technologies must deal with these additional complex regulatory requirements. More often, manufacturers of medical devices with wireless functionality (such as Bluetooth) must now address information security and electrical safety requirements in addition to standard regulations in some countries. Emergo has assisted several clients achieve regulatory approval for their wireless medical devices, and can fully support your marketing authorization effort as well.
“Regulatory Roadmaps” for Wireless Technology Compliance
If you have already added or are considering adding wireless technology to your medical device, Emergo can identify pertinent regulatory requirements you will need to address in specific countries. For example, if you’re a wireless device manufacturer who has added radio frequency identification (RFID) to your product, we can point out requirements of given countries’ communications regulators such as the US Federal Communications Commission (FCC) in addition to standard medical device regulatory requirements.
As part of our wireless medical device technology consulting service, we can identify technical parameters including allowable frequencies, output power and other related issues associated with wireless and mobile products.
Registration of wireless medical devices
Once you have decided on which markets to seek approval for your wireless medical device, Emergo can prepare and manage your registration from start to finish. Our service includes support for spectrum or radio frequency approval from your chosen markets’ communications authorities, as well as for meeting requirements of medical device market regulators.