Oncotherm achieves MDR Certification
We are proud to share that Oncotherm has officially achieved Medical Device Regulation (Regulation (EU) 2017/745 on Medical Devices – MDR) certification under the European Union’s regulatory framework. This major milestone highlights our dedication to maintaining the highest standards of safety, quality, and innovation in the field of oncological medical technology.
The MDR certification represents a critical step for medical device manufacturers operating within the EU. It emphasizes a more robust regulatory process, focused on ensuring the safety and performance of medical devices throughout their entire lifecycle. This certification required an extensive evaluation of our internal processes, clinical practices, and product documentation.
For Oncotherm, this achievement is more than just a regulatory requirement – it is our mission: improving patient outcomes through reliable, cutting-edge cancer treatment technologies. With the MDR certification in place, healthcare providers and patients across Europe can continue to place their trust in our products, confident in their safety and clinical efficacy.
We would like to extend our deepest gratitude to our dedicated employees, partners whose hard work and collaboration made this accomplishment possible.
