Navigating Regulation for Medical Devices & What to Look For in a SAR Testing Lab

Navigating Regulation for Medical Devices & What to Look For in a SAR Testing Lab

Any medical device will undergo significant regulation by a variety of regulatory agencies, and it’s easy to understand why this is the case. These are potentially life-saving devices that need to be able to perform a specific task without interfering with other devices, being disrupted by other devices, and without harming anyone. For anyone manufacturing these devices, it can be difficult to navigate regulation for medical devices and ensure that you’ve chosen the right SAR testing lab to help you prove compliance. Continue reading to learn what to keep in mind when choosing a testing lab for wireless medical devices and how RF Exposure Lab can make things simple for you.

Wireless Medical Devices

Wireless medical devices use radio frequency (RF) energy to complete functions that require wireless RF communication through WiFi, Bluetooth, or cellular to support healthcare. These wireless functions include controlling and programming a medical device, remotely monitoring patients, or transferring patient data from a medical device to another platform. 

Regulation for Medical Devices and What to Look For in a Testing Lab

Wireless medical devices have the potential to save countless lives, but these devices can’t be placed on the market unless they can prove compliance and pass regulatory testing. However, not all testing labs are equal. When choosing the right lab for your needs, consider whether or not the lab you may work with has the knowledge and expertise to accurately test your device.

In addition to this, keep in mind that different governing bodies manage these regulations depending on the country where the device will be sold. In the US, the Federal Communications Commission (FCC) manages public use of the RF spectrum that these wireless devices use to operate. However, the FCC coordinates with FDA policies regarding wireless medical devices, which can further complicate regulation for medical devices.

Although FCC SAR testing results are accepted in many countries, this isn’t the case for all countries. It’s important to let the lab you’ll be working with know which countries you’d like to distribute your product in and ensure that they have the knowledge to provide results that will be accepted in each country of distribution. A knowledgeable SAR testing lab will work with you to make sure that your wireless device undergoes all appropriate testing and will properly document this testing. 

How RF Exposure Lab Can Help

As you can see, navigating regulation for medical devices is not a simple or easy task. It can be confusing and time-consuming to determine which requirements and tests apply to your product. Some wireless medical devices don’t require SAR testing, and it’s beneficial to work with a lab that will let you know when this is the case for your product.

RF Exposure Lab has considerable experience and expertise in SAR compliance testing for global markets. Jay Moulton, Owner and Vice President, was even involved in creating the testing and methodology that has been used to establish today’s FCC requirements. We also remain up-to-date on the latest regulation changes to ensure we only perform relevant tests.

We are the only standalone SAR testing lab in the United States and apart from offering testing services for client products, we also provide design suggestions for manufacturers to guarantee that they meet all SAR testing requirements before completing the design process.

With help from RF Exposure Lab, you can avoid costly compliance failures and product redesigns, which will allow you to save money and get your product on the market as quickly as possible. For SAR testing provided with speed, expertise, accuracy, and integrity, contact us to get a quote today.