Safe-n-Medtech calls its 54th month management committee meeting in Bilbao on 20 – 21 September 2023 to start the OITB Pathway.
All nine work package leaders of safenmt will present the final progress of their work packages.
Dr. Luc Van Hove of MARACA International , as WP7 Leader, Regulatory and Ethics, will present the final update of the medical device and IVD harmonized standards to be used for the development of nanotechnology-based medical devices. He will also present the report on applying ethical behavior in the development of nanotechnology-based medical devices.
Moreover, Luc reviewed the Quality Management Systems (QMS) and Technical Documentation (TD) of several test case partners, identified gaps and proposed resolutions to bring their QMS and Technical Documentation into compliance with the MDR, the IVDR or ISO 13485:2016. He developed regulatory strategy plans for several partners and improved the risk documentation of several nanotechnology-based devices to be in compliance with ISO 14971:2019. Luc also developed scientific validity reports with systematic literature searches to support the clinical evaluation of some medical devices and IVDs and he was a medical member of the NoCanther clincial trial Safety Board.
MARACA International is also heavily involved in the creation of the OITB Pathway portal.
The OITB Pathway company is created as a single-entry commercial enterprise portal to link medical device and IVD clients with partners who offer different specialized services to research and develop medical devices and IVD to a successful registration in Europe.
MARACA developed the Quality Management System for the OITB Pathway company in compliance with ISO 9001:2015.
MARACA International will offer its regulatory, quality, and clinical services through the OITB Pathway to the many clients in need of such services.