De-risk your digital health technology development by applying appropriate regulatory framework at early stage.
300+ innovative device technologies
From mobile health-related applications, wearable connected devices to Artificial Intelligence (AI), Augmented Reality (AR) and software that supports clinical decisions or monitors patient’s activities, digital health technologies have been driving a revolution of health care.
We offer the following services to clarify the regulatory process and to ensure that your digital health innovations meet appropriate standards for Medical Device (MD) software development, validation, safety, performance, and data security.
- Due Diligence, regulatory strategy and roadmap
- MD qualification & classification and claims positioning
- EU Notified Body selection and US FDA consultations
- MD Software development & validation
- IEC62304/ISO62366 conformity
- ISO13485 Quality Management System
- Applicability of Real World Evidence where appropriate
Our consulting services apply but are not limited to the following types of digital technologies:
- Mobile medical application
- Software as Medical Device (SaMD)
- Wearable/Connected devices
- Digital/Artificial Intelligence
- Predictive/Diagnostic/Therapeutic algorithm
- Clinical decision software
- Virtual/Augmented reality
- Expert system/Robotic system
- Computer Aided Diagnosis (CADe, CADx) / PACS
- Analysis of Real World Data