Digital Health is one of the fastest-growing segments in health care: mobile health-related applications, e-health, telemonitoring, telemedicine, software that supports clinical decisions or monitors patient’s activities.
Don’t miss the chance and de-risk your digital health technology development by applying appropriate regulatory framework at early stage.
RPN offers the following services to clarify the regulatory process and to ensure that your digital health innovations meet appropriate standards for Medical Device (MD)
- Regulatory support and strategy
- Due Diligences and roadmap
- Medical device qualification & classification
- Promotion & claims positioning
- EU Notified Body selection and management of CE marking procedures
- ISO13485 Quality Management System
- US FDA regulatory support