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Software as a Medical Device Regulatory Support

Expert Guidance for Software as a Medical Device Compliance

Whether standalone, embedded, or artificial intelligence (AI)-driven, software as a medical device (SaMD) must navigate complex, overlapping regulatory requirements, including medical device regulations, AI legislation, and software standards. Without a clear strategy, these interlinked requirements can lead to delayed regulatory approval and market access.

Our expert team works closely with your software development team from the start to align regulatory strategy with your SaMD development goals and technical processes. We will help you to accelerate approvals, reduce risk, and build a scalable, audit-ready strategy that evolves with your product.

How We Help Clients

Navigate the full spectrum of regulatory requirements, including:

Our comprehensive range of services includes:

Regulatory strategy development tailored to your SaMD type, target market, and risk class
Identification and interpretation of applicable standards and regulations across jurisdictions
Product classification and qualification, including AI-enabled systems and borderline cases
Gap analysis of your QMS and technical documentation

Compliance adaptation tailored to your development model (e.g., Agile, hybrid, DevOps)
QMS implementation and optimization
Preparation of technical documentation and submission support for product market authorization
Design non-clinical, analytical, and clinical evaluation strategies, including real-world evidence use

Audit preparation, remediation, and ongoing compliance support, tailored to your operational scale
Authority interaction management, including strategic interaction packages preparation and follow-up, e.g., PreSubs, scientific advice
Customized training on regulatory strategy for software compliance and emerging AI regulations

Why Partner With Us for Your SaMDs Regulatory Strategy?

We combine strong knowledge of medical device regulations with hands-on software regulatory experience to help you bring safe, compliant, and innovative SaMDs to patients.

In-house team of experts across regulatory, clinical, and quality systems with deep understanding of SaMD’s technical and practical challenges
Tailored services that integrate regulatory strategy into your development workflow and technology
Industry leaders dedicated to continuous learning and staying at the forefront of evolving SaMD regulations
Proven track record with 100+ submissions and direct interactions with the Food and Drug Administration, European Medicines Agency, European Union Member State agencies, and notified bodies