MARACA’s CEO Dr Luc Van Hove will be participating in the worldwide regulatory professionals’ convergence (RAPS).
Taking place in Vancouver, Canada, from 1 October to 4 October, the event will include informal discussions on key challenges facing today’s regulatory professionals, volunteer opportunities and real-time industry news and information, and an opportunity to talk with members of the Regulatory Affairs Certification Board and RAC holders about where the RAC credential can take your career.
Dr Luc Van Hove will be discussing the latest advances in regulatory affairs. He will review in particular progress of small-medium enterprises (SME) transition efforts to the new MDR. He will alert that it is already very difficult for SMEs to find a notified body to review their design dossier for certification.
Having sufficient clinical evidence for their medical devices is the other hot item. He strongly recommends SMEs to start post-market clinical follow-up (PMCF) studies now to have sufficient clinical data in support of their design dossier.