RF Energy is an exciting technology that offers medical technology companies many opportunities. Compliance, however, is often an issue for these budding devices. A lack of expertise results in a heavy investment of time or money to solve compliance problems. With so much room for growth in RF applications, where should organizations turn to solve their medical device compliance issues.
RF Technology Applications
The applications of RF technology are expanding all the time. Today there are RF Energy applications for ablation procedures, spine surgeries, oncology, and electroporation to name a few. But each of these devices and corresponding processes must adhere to the current regulations. These medical device regulations are changing too, and often require expertise to comprehend and properly implement them into product design.
For organizations that wish to produce and supply their product at the international level, regulations change depending on the country in which you are operating. All these contributing factors lead to a complex process that demands time, money, and expertise. Without the proper support, medical device compliance issues can completely hinder a product.
Maintaining Compliance for RF Technologies
Compliance for RF technology is demanding. It takes an expert level of understanding to translate regulations into actionable steps for a product. Experts across every target audience and country are not easy to come by. For medical device manufacturers, relying on a team of dedicated experts is not only easier; sometimes it is necessary for the product’s success.
The proper guidance for RF technologies should consider the device in question, and the current regulations for devices that utilize radio frequencies. After examining current regulations, changes to the design and manufacturing process can be made to execute the product. After ensuring that the product procedures meet the required industry standards, manufacturing and distribution can begin. But maintaining compliance doesn’t end here; instead, compliance must be maintained across the device’s lifespan.
How Minnetronix Addresses Compliance Issues
Minnetronix incorporates considerations for medical device regulations into the design process and supports them across the lifespan of the product. After your product graces the market, compliance must shift to post-market activities. These activities include post-market surveillance, reportability activities, ensuring maintained manufacturing compliance, and investigating customer feedback.
These activities can be an impossibility for some organizations. Minnetronix offers full lifecycle solutions to evaluate the regulations in your industry and ensure that your products won’t be hindered by compliance issues. To see what Minnetronix can do for your organization, contact us now.