Intertech Engineering Associates, Inc.

Full Spectrum Software (formerly Intertech Engineering Associates) is a specialized engineering firm focused on regulated medical device software development. Operating since 1982, the company brings over 40 years of experience to medical technology product development, claiming to have helped bring more than 300 products to market.

The firm specializes in end-to-end product development for regulated medical devices, including diagnostic equipment, therapeutic devices, surgical robotics, life sciences equipment, and digital health systems. Their service portfolio encompasses software engineering, systems engineering, regulatory compliance support (including FDA submissions), verification and validation, cybersecurity for medical devices, and AI/ML integration. They focus specifically on navigating complex regulatory frameworks including FDA requirements and international standards like IEC 62304.

Full Spectrum positions itself as a partner for medical device companies seeking to navigate the intersection of innovation and regulatory compliance, with particular depth in embedded controls, multi-platform applications, cloud-based analytics, and mobile platforms for healthcare applications.

Choose Full Spectrum Software when developing a regulated medical device that requires deep expertise in both software engineering and FDA regulatory pathways. Their four decades of specialization mean they understand the nuances of medical device lifecycle management, from design controls to post-market surveillance.

Expect a partner that can navigate complex regulatory requirements while delivering technical solutions across embedded systems, cloud platforms, and mobile applications. Their experience with over 300 product launches suggests they can anticipate common pitfalls in the medical device approval process.

Full Spectrum Software operates exclusively in the regulated medical technology sector, serving diagnostic medical device manufacturers, therapeutic device companies, surgical robotics developers, and life sciences equipment producers. Their healthcare specialization centers on navigating FDA regulatory requirements, implementing medical device cybersecurity frameworks, and ensuring compliance with international standards like IEC 62304 and ISO 13485.

The company's expertise spans the unique challenges of medical device software development, including design controls, risk management per ISO 14971, verification and validation protocols specific to medical devices, and emerging regulatory considerations for AI/ML-enabled medical devices.

Medical device manufacturers, medtech startups, and life sciences companies developing Class II or Class III regulated devices that require FDA 510(k) or PMA approval. Organizations developing surgical robotics, diagnostic equipment, or therapeutic devices with complex software components who need a partner experienced in IEC 62304, cybersecurity risk management, and AI/ML regulatory frameworks.