Visitors to MARACA International’s booth at the MEDTECH MEETUP in Brussels will receive a 25% discount code for your onside registration to the meeting.
Taking place on 22 March, visitors to the event can speak to MARACA International’s physician Dr Van Hove. He can answer all the questions you have on your medical device or in-vitro diagnostic device (IVD) registrations in Europe or the US.
MARACA International offers a full suite of regulatory, medical and clinical services that help bring your devices to the market in Europe or the US. Get your free consultation at the meeting.
MARACA offers training on the medical device regulations (MDR) and (in-vitro diagnostic device regulations (IVDR). MARACA can assess your company’s status to get into compliance with the MDR or IVDR or with ISO 13485:2016.
MARACA can help develop technical files or design dossiers, run systematic literature reviews, and can help you develop your scientific validity report, your clinical validity report or your clinical evaluation report (CER) or performance evaluation report (PER).
The company’s board-certified physician can approve your clinical evaluation reports (CER) / project evaluation report (PER) as medical evaluator. If the CER identifies a need for a clinical investigation, he can develop an executive summary for a clinical study and can also develop a post-market clinical follow-up (PMCF) plan when on-market studies are needed.
MARACA can organise your clinical study and develop the study plans and reports. When adverse events happen, the company can handle your risk management.
MARACA’s physician will assess the patient impact for harm, formulate a risk-clinical benefit summary for your device and make a recommendation on how to mitigate the risks.
When you are looking for service excellence for your regulatory, medical or clinical activities come and talk to MARACA at its booth.