Are your medical devices compliant to performance and electronic equipment safety standards?
As a general rule, medical electronic equipment needs to be tested for safety and performance to meet government regulations before the product is introduced into the market.
IEC 60601-1 is the de facto standard widely accepted by countries around the world to test for risks inherent in medical devices. With the wide range of medical devices that have different applications, there are additional collateral standards defined within the 60601-1 standard for the products to be tested for aspects of safety and performance. Since the inception of the IEC 60601 standard, there have been several updated editions and changes to the verbiage which makes the standards difficult to navigate through.
Today, many medical devices are “connected” devices and will be operated and controlled by software. That software will include embedded firmware and a user interface like a mobile or SaaS-based application which is used to operate the device and to store and analyze data. Some devices may operate together in clusters that require complex software to talk to each other. The software should be tested for quality of functionality and performance as well as for defects that may pose security vulnerabilities. Not only will the software require full quality control, but the software development process or the software delivery lifecycle (SDLC) must be assessed in order to conform to international standards as defined by IEC 62304. This standard applies to the development and maintenance of medical software when the software is itself is a medical device, or, the software is embedded or an integral part of the final medical device.
By getting your product validated to the global standards, by independent accredited 3rd-parties, will not only help your product meet the global benchmark but also help reduce the risk of liability.
MiCOM Labs, an accredited global regulatory testing and certification lab in partnership with QA Consultants, the largest software testing lab in North America, will help you navigate through the complexities of the regulatory and software compliance audits, testing and certification needed for your product to meet the FDA and AAMI guidelines.