Craft your optimal regulatory strategy for Digital Medical Devices (DMD)

Entrust us with the audit of your health software to determine if it needs to comply with digital Medical Device (MD) standards and regulations. Benefit from our strategic advice to set a clear, efficient compliance roadmap right from the start.

The challenge

Navigating the classification of Software as a Medical Device (SaMD) involves clear challenges: accurately identifying which parts of your software meet the Medical Device criteria amidst global regulatory differences and ensuring precise scope definition to avoid compliance risks without overburdening non-Medical Device components. This careful balance is crucial for timely market access and innovation.

Our solution

With our expertise in health software auditing, we offer a comprehensive approach to ensure compliance within the regulatory framework of the health sector. Our services include:

• Precision classification: Accurately identifying software features that qualify as Medical Devices for targeted compliance.
• Custom compliance roadmap: Developing tailored strategies to streamline your product's path to market with focused regulatory adherence.
• Risk mitigation: Implementing proactive measures to minimize compliance risks, ensuring your product's innovation and market positioning are secure.