Regulatory Planning and Submissions
Through our regulatory services, we identify all the necessary regulatory requirements your medical device shall meet. We provide a structured approach to identifying the relevant guidelines, preparing submissions, and ensuring conformity with preclinical and clinical standards.
- Risk classification of the device
We assess the risk classification of your device based on its intended use, technology, and potential patient impact. This classification determines the regulatory pathway and the extent of testing and review required.
- Strategy planning for regulatory compliance
Our team develops a tailored regulatory compliance strategy, guiding you through the necessary steps to meet all relevant standards. We prepare the required documentation and help anticipate potential regulatory challenges, ensuring a smooth approval process.
- Planning of preclinical conformity and clinical evaluation
We plan and coordinate the preclinical testing and clinical evaluations required to demonstrate your device’s safety and performance. Our approach ensures that all necessary studies are conducted in line with regulatory standards, minimizing delays and ensuring compliance.