The certified Medical Analysis API by ACTIMI is a robust solution designed to streamline the integration of medical data analysis into various applications. With a focus on compliance with MDR IIa standards, it offers a fast-track approach to market product launch while ensuring substantial savings on certification costs, estimated between €150,000 to €200,000. The API facilitates the processing of device data crucial for developing digital health solutions, including lifestyle applications.
Additionally, the platform, compliant with international standards such as ISO 13485 and GDPR, allows for seamless incorporation into existing systems, providing complete documentation for developers. This helps medical practitioners and startups simplify their pathways to certification, ultimately promoting quicker healthcare innovations and effective patient monitoring systems.
For organizations eager to expedite the rollout of their medical products, this API represents a transformative opportunity, allowing stakeholders to bring their solutions to market efficiently without compromising on compliance or functionality.
What is MDR certification?
MDR certification refers to the Medical Device Regulation certification required for products aimed at supporting medical purposes, ensuring they meet safety and efficacy standards.
Why do I need MDR certification?
MDR certification is essential to legally market medical devices in the EU. It verifies that your product is compliant with health, safety, and performance requirements.
What happens if I don't comply with MDR regulations?
Non-compliance with MDR regulations can lead to fines, product recalls, and the prohibition of your device in the EU market.
How can Metaistic help with MDR certification?
Metaistic can assist by providing expert consulting services for a smooth integration process, ensuring products meet regulatory requirements, and streamlining the journey to MDR certification.
