DOSIsoft Commitment to EU MDR Compliance
Adopted in April 2017, the Medical Device Regulation (MDR) (EU) 2017/745 became applicable in the European Union on May 26, 2021, replacing the previous medical device directives (93/42/EEC and 90/385/EEC). This regulation reshapes the European legal framework for medical devices.
DOSIsoft is actively engaged in supporting MDR implementation. The company has reinforced its internal Quality System to align with the updated regulatory landscape, reaffirming its commitment to the highest standards of safety, performance, and compliance.
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“It is a real achievement and a collective work for DOSIsoft to provide all answers to our notified body, along with updated technical documentation and additional performance and clinical data,” highlights Marc USZYNSKI, CEO at DOSIsoft S.A., “This new version of PLANET® Onco Dose, fully compliant with the EU MDR requirements, positions PLANET® ahead of the competition. We are looking forward to seeing patients across the EU Mark region benefit from this safe and effective device.”
“From clinical research perspective, the hospital centers can access the new functionality IBSI-compliant (Image Biomarker Standardization Initiative) texture radiomics, through current integrated PLANET® platform to carry out diagnostics, analytics, and AI-based innovative research projects. This new feature and the global PLANET® development program are also perfectly aligned with DOSIsoft participation in the EU Thera4Care project, aiming at transforming cancer treatment through the power of radiotheranostics.” adds Marc USZYNSKI.
To learn more about PLANET® Onco Dose, the patient-specific Theranostics solution, visit DOSIsoft at JFMN (Booth #6a, March 20–23, 2025), as well as at upcoming SNMMI, EANM Annual Meetings, and other key nuclear medicine events.
About Regulation (EU) 2017/745
The regulation aims to ensure the smooth functioning of the internal market as regards medical devices, taking as a base a high level of health protection for patients and users, and taking into account the small- and medium-sized enterprises that are active in this sector. At the same time, this Regulation sets high standards of quality and safety for medical devices in order to meet common safety concerns as regards such products.
About PLANET®
PLANET® Onco Dose Edition 3 is developed by DOSIsoft SA in France. It is a Class IIb CE-marked medical device under MDR (EU) 2017/745 and is currently FDA 510(k) pending. Availability of the product or specific features may vary by country and regulatory approval status.
