A small Romanian company specialized in software solutions for medical imaging and teleradiology wants to prove its compliance to the Medical Device Regulation (MDR) and to obtain the CE-Marking.
The partner sought should be able to support the Romanian company to prepare the technical documentation and other documents in order to obtain the CE-Marking, class IIb, for the medical software.
The cooperation targeted is services agreement with a company located in any EEN country.
The company is well inserted in the medical landscape of Romania, mainly in the West Region. It offers several integrated software solutions for medical imaging, teleradiology and patient data management
The company developed high performance software solutions in the field of web RIS / PACS (Radiology Information System /Picture Archiving and Communication System) and related.
The company is already ISO 9001 and ISO 13485 certified.
At this stage, the company wants to obtain product certification for its software products and the CE-Marking, class IIb, according to MDR 2017/745.
The potential partner is a company that bears with the proper know-how and is able to support the Romanian company for preparing its application for the CE-Marking.
The cooperation type should be services agreement and the partner is sought in any EEN country.
- Type of partner sought: The partner sought should have expertise in working applications to obtaining the CE marking, preferable for software products.
- Specific area of activity of the partner: The partner sought should be a specialized consultancy company or a certification advisor located in any EEN country.
The role of the partner will be to assist the Romanian company to obtain the CE-Marking class IIb for its medical software products, mainly by preparing the appropriate application.
The targeted services agreement should have a partner in any EEN country.
The company is well inserted in the Romanian medical software market and offers its high-quality, own products.
The company is ready to prove the compliance of its products with the requirements of most medical imaging devices.
Already on the market