In the rapidly evolving world of healthcare technology, Software as a Medical Device (SaMD) has emerged as a transformative force, enabling innovative solutions for diagnosis, treatment, and patient care. However, navigating the complex regulatory landscape for SaMD products can be challenging.
At Innovenn, we specialize in providing comprehensive regulatory affairs services to help SaMD companies bring their products to market and in compliance with global regulations.
SaMD is defined by the International Medical Device Regulators Forum (IMDRF) as “software intended to be used for one or more medical purposes without being part of a hardware medical device”1. Examples include clinical decision support systems, diagnostic algorithms, and remote monitoring applications.
Regulatory requirements for SaMD vary across regions, with the U.S. Food and Drug Administration (FDA), European Union (EU), and other global health authorities each having their own frameworks.
Key challenges include:
We offer end-to-end regulatory services tailored to support development, approval and adoption of each unique SaMD. Our team of experts help you assess if your product meets regulatory requirements, from initial planning to post-market surveillance.
We work with you to develop a customized regulatory strategy that aligns with your product’s intended use, target markets, and development timeline.
Our services include:
Preparing for regulatory submissions is critical to avoiding delays and facilitating a smooth review process.
Our pre-submission services include:
We assist with the preparation and submission of all required documentation, including:
510(k), De Novo, or Premarket Approval (PMA) applications, including Software Precertification Program (if applicable)
Technical documentation, including clinical evaluation reports (CERs) and post-market surveillance plans
Technical documentation, including clinical evaluation reports (CERs) and post-market surveillance plans
A robust QMS is essential for SaMD compliance. We help you establish and maintain a QMS that meets regulatory requirements, including:
We support the generation of clinical evidence to demonstrate the safety and effectiveness of your SaMD product. Our services include:
Regulatory obligations continue after market approval. We help you implement post-market surveillance systems to monitor product performance and to support ongoing compliance.
Our services include:
Navigating the regulatory landscape for SaMD products requires specialized expertise and a deep understanding of both software development and medical device regulations. At Innovenn, we combine technical knowledge with regulatory experience to provide tailored solutions that accelerate your path to market. Our commitment to excellence and our mission to improve patient lives drive us and we aim to achieve the highest standards while supporting the safety, efficacy, and usability of your product.
Whether you’re developing a new SaMD product or expanding into new markets, Innovenn is your trusted partner for regulatory success. To learn more about Innovenn’s regulatory services for SaMD products, contact us directly to discuss your specific needs.
Global reach from Wisconsin HQ. Serving clients in the US, EU, UK & Canada
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Madison, WI 53719
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