Full Spectrum Software has been the go-to medical device software development partner for many world-leading medical device companies for over two decades. Few companies can boast the breadth and depth of expertise Full Spectrum has in this field. With a background of over 450 medical software products, including many Class III devices, Full Spectrum can help you build a quality medical product you can count on!
When choosing a medical software development partner, it’s important to choose a company that values the affect the products have on people’s lives. We take great pride in developing products that are ultimately helpful for everyone’s well-being. Full Spectrum’s dedication to produce the highest quality software products is evidenced by our values. With a senior level engineering team committed to developing high-quality software for complex medical devices, you can be assured of a product you can rely on.
Medical device software development at Full Spectrum Software follows a mature Quality Management System (QMS) built per ISO 13485:2016 standards and adheres to IEC and federal regulations, including but not limited to, 14971, 60601, 62304, HE75, CFR 820.30, and HIPAA. Many of our medical software products have received FDA approval within record times. We have also developed many Class I and Class II devices and understand not all medical software products have the same level of regulatory requirements. We will develop a customized approach that best serves your needs. We often work with many clients to develop Prototypes and Minimum Viable Products (MVPs) in both regulatory and non-regulatory environments.
Our portfolio includes a wide variety of medical device software products in: