A clinical device trial is almost essential for bringing devices to market in compliance with the MDR. However, it should be conducted carefully and only to the extent necessary. Thorough and comprehensive preliminary work can significantly save costs and time.
Clinius has developed an application that utilizes OpenAI’s generative artificial intelligence and large language model (LLM) for the evaluation of medical articles. This innovative application enables the efficient assessment of extensive literature findings required for MDR and IVDR clinical evaluations.
Clinius offers accredited training focused on the requirements of the health technology with it's partner Comply Guru. The training offer covers the key legislation and requirements of the industry, including ISO 13485 and ISO 14971 standards as well as MDR, IVDR, FDA QSR and MDSAP legislation. Trainings are held either in eLearning (24/7) or blended learning formats in English. See the attached training guide for more details.
Clinius is a pioneer of clinical device trials in Finland. We have more than 15 years of experience in both clinical trials and cooperation with healthcare organizations. We carry out the planning, preparation and implementation of the trial taking into account the requirements of both the MDR and the ISO 14155 clinical research standard.
Are you looking for a partner for your clinical device research? A common vision with the partner, the partner's wide-ranging vision of the research need, and the partner's experience in the practical implementation of the research are essential in the implementation of research. The aforementioned is best realized when the cooperation project is on the move in time.
Together with its partner Comply Guru, Clinius offers a new, internationally accredited training service in Finland. Available anytime and anywhere (24/7) eLearning will cover the key legislative requirements related to healthcare technology (MDR, IVDR, FDA QSR and MDSAP) as well as standards ISO 13485 and ISO 14971. The training ranges from the foundation level up to practitioner and lead auditor level. eLearning offers a learning environment with interactive and engaging content, continuous learning monitoring and a final exam to obtain certification.
Clinius conducted a survey amongst its customers. Our Net Promoter Score (NPS) was a whopping 73. The result is the best in our measurement history!
Thanks for that goes to our specialists, who have made our customers so satisfied thanks to their professionalism and customer-oriented way of working.
We will continue to aim for high-quality and reliable operations.
European Counsil supports European Commission's proposal to delay the transitional deadlines for medical devices under the Medical Devices Regulation (MDR). According to the proposal, the deadline for the transition period for high-risk class III and IIb products would be moved to 2027, and for lower-risk class I and IIa products to 2028. The justification for extending the transition periods is in particular the insufficient capacity of the notified bodies - the conformity assessment of thousands of products is still in progress, and not all of them have time to be approved in accordance with the current MDR requirements within the framework of transition schedules.
We have moved to new office facility in Vallila, Helsinki. Our new street and postal address is:
Clinius Oy
Kuortaneenkatu 2
00510 Helsinki
Finland
We have renewed our web page. The goal has been that the content would be clearer than before and that our central services would be much easier to find. We would love to hear what you think about our site. You can send us your comments either directly by email or by using our contact information feedback form. Thank you in advance for your comments!
