At Innovenn, we offer end-to-end medical device development and regulatory affairs consulting services for a wide range of product and therapeutic areas, enabling us to support companies in navigating the complex regulatory landscapes of the FDA, EU, and other global regulatory authorities.
The rise of digital health has transformed the medical landscape, and Innovenn is at the forefront of this evolution. Innovenn’s team provides comprehensive support for the design and development of Software as a Medical Device (SaMD) and digital therapeutics, facilitating compliance with regulatory requirements while maximizing product adoption and commercial potential.
At Innovenn, we go beyond consulting—we partner with innovators to bring safe, effective, and user-centered digital health solutions to market. Our collaborative approach ensures a deep understanding of your unique product, whether you’re developing an AI-powered diagnostic tool, a life-saving connected medical device, or a transformative digital therapeutic.
From early workstreams focused on identifying user preferences and defining detailed business and user requirements for software development, to full-service project execution, clinical evaluation, validation, and evidence generation, we support clients throughout the entire product lifecycle. Our services are designed to enable successful serial global regulatory submissions and facilitate robust post-market governance and surveillance planning. We help clients navigate the complex and evolving landscape of digital health product development, including challenges related to data privacy, cybersecurity, and strategic alignment.
We combine regulatory strategy, Human Factors engineering, clinical validation, and software product development expertise to help you navigate the complexities of FDA, EU MDR, and global digital health regulations. From early-stage concept through regulatory submission and post-market strategy, we deliver tailored, scalable solutions that reduce risk, accelerate timelines, and drive real-world impact.
Let us help you bring your digital health innovation to life with confidence and clarity.
Artificial intelligence and machine learning are revolutionizing healthcare, offering unprecedented opportunities for innovation. We specialize in guiding companies through the development, validation and regulatory approval of AI-driven medical technologies. Our services include algorithm development, validation, and risk management, as well as addressing regulatory expectations for transparency, explainability, and bias mitigation. Whether your product involves diagnostic imaging, predictive analytics, or personalized treatment recommendations, we support your product so it meets the highest standards of safety and efficacy.
From concept to commercialization, we provide tailored support for a wide range of medical devices, including Class I, II, and III devices. Our team assists with design controls, risk management, usability testing, and regulatory strategy to facilitate compliance with global standards. Whether you’re developing a novel surgical instrument, a diagnostic tool, or a therapeutic device, we bring deep expertise to every stage of the product lifecycle, helping you achieve timely approvals and successful market entry.
Combination products—where a drug, biologic, and/or device are integrated into a single therapeutic solution—present unique regulatory, technical, and lifecycle challenges. Whether you’re developing a drug-device, biologic-device, or drug-biologic combination, our team brings deep expertise in navigating FDA and global regulatory requirements, including those under 21 CFR Part 4, 21 CFR 820.30, IEC 62366, and CGMP compliance.
We provide end-to-end support, from early-stage product definition and regulatory strategy through Human Factors validation, clinical study integration, submission planning (IND, NDA, BLA, 510(k)/PMA, or De Novo), and post-market compliance. Our cross-functional approach ensures seamless integration of all components—drug, biologic, and device—while maintaining alignment with evolving regulatory expectations and patient safety standards.
Wearable technologies are transforming patient care by enabling continuous monitoring and personalized health insights. We specialize in the development and regulatory approval of wearable medical devices. Our services encompass hardware and software integration, clinical validation, and regulatory strategy, supporting your wearable product so they meet the stringent requirements of global regulatory authorities while delivering meaningful health outcomes.
At Innovenn, we combine scientific expertise, regulatory knowledge, and a passion for innovation to help our clients bring groundbreaking products to market.
Our expert, cross-functional team goes beyond traditional consulting; we act as strategic partners, aligning deeply with your vision, technical priorities, and regulatory pathway. Through a highly collaborative and tailored approach, we help you translate complex challenges into actionable strategies that accelerate development and de-risk your product journey. Whether you’re building an AI-driven diagnostic, a lifesaving connected device, or a breakthrough digital therapeutic, we bring the regulatory, clinical, and Human Factors expertise needed to navigate evolving global frameworks with confidence. From concept through commercialization, we deliver solutions that are not just compliant, but impactful, scalable, and user-centered.
To learn more about our products portfolio, contact us directly to discuss your specific needs.
Global reach from Wisconsin HQ. Serving clients in the US, EU, UK & Canada
6410 Enterprise Lane
Suite 230
Madison, WI 53719
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