MARACA International received the AI Acquisition International 2018 global excellence award for Recognized Leader in Quality Control Services – Belgium.

AI awarded our MARACA International focus on service excellence for our regulatory, medical, clinical and quality services to MD and IVD companies, clinical laboratories and notified bodies.
Dr. Luc Van Hove, CEO, said “we are happy receiving this AI award for global excellence”. This strengthen us in our focus on providing the best possible MARACA services to our customers.

MARACA International provides regulatory and clinical service excellence to register your MD and IVD products in Europe and the USA. We identify the gaps against the new MDR, IVDR and 21CFR. Provide training to understand these new regulations. Address the gaps in your Design Dossiers and represent you with the Notified Bodies, Competent Authorities and FDA. MARACA provides with our physician a unique CER/PER review service. Our physician can develop your PMCF/PMPF plan and assist you with your clinical studies and risk management.

MARACA International has announced it will be present at the EU MD IIS Meeting in Brussels.
MARACA International is a Belgian consulting company providing service excellence for regulatory, quality, clinical and medical affairs assignments. The company serves medical device, in-vitro diagnostic device (IVD) and pharmaceutical companies, as well as clinical laboratories, notified bodies and governmental agencies.
These services support your product registrations in Europe under the Medical Device Directive (MDD), In-Vitro Diagnostic Device Directives (IVDD), Medical Device Regulation (MDR) and In-Vitro Diagnostic Device Regulation (IVDR) regulations. In the US, MARACA’s services support your submissions to the US Food and Drug Administration (FDA).
MARACA International’s services include training, quality system management, risk management, development of design dossiers and technical files, registration of devices, clinical evaluation reports, scientific validity reports and post-market follow-up plans and reports.
Visit MARACA International at the meeting from 16 May to 17 May at Sheraton Brussels Airport Hotel.

Visit first our MARACA International booth at the MEDTECH MEETUP in Brussels and get your 25% promo discount code for your onside registration to the meeting. Then come back and ask Dr. Van Hove, our physician, all questions you have on your Medical device or IVD registrations in Europe or in the USA.

MARACA International offers a full suite of regulatory, medical and clinical services that help bring your devices to the market in Europe or the USA.

Get your free consult at the meeting.

MARACA offers training on the MDR and IVDR regulations. We can assess your company status to get into compliance with the MDR or IVDR or with ISO 13485:2016. MARACA can help develop the Technical File or Design Dossier. We can run systematic literature reviews and help you develop your scientific validity report, your clinical validity report or your Clinical evaluation report (CER) or Performance evaluation report (PER). Our board certified physician can approve your CER/PER as medical Evaluator. When the CER identified a need for a clinical investigation. He can develop an executive summary for a clinical study. He can also develop a Post-Market Clinical Follow-up (PMCF) Plan when on-market studies are needed. MARACA can organize your clinical study and develop the study plans and reports.

When adverse events happen, we can handle your risk management. Our physician will assess the patient impact for harm. He will formulate the risk-clinical benefit summary for your device. Where after he’ll 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 us at the MARACA booth.

Luc Van Hove, Founder of MARACA International and Principal Consultant is presenting on Companion Diagnostics IVDR regulation implementation from an IVD Company perspective at the RAPS Netherlands Chapter Meeting, 24 November in Amstelveen, The Netherlands.  Learnings: Understanding the difference between Companion diagnostic devices and Complementary diagnostic devices. The implementation steps of the IVDR for these products. What pathway to follow.

See also e-learning training on Companion Diagnostics.

MARACA International is a consulting company providing service excellence in Regulatory, Clinical and Medical Affairs services to Medical Device, IVD and pharma companies, clinical laboratories and notified bodies.

MARACA International will be at the RAPS Regulatory Convergence, National Harbor, Washington DC Waterfront, 9-12 September, 2017.

You can meet Dr. Van Hove at the convention by contacting him at maracainternational.com