MARACA International bvba of Rotselaar at MEDICA 2018 in Düsseldorf -- MEDICA - World Forum for Medicine

MARACA International bvba

Heirbaan 143, 3110 Rotselaar
Belgium

This company is co-exhibitor of
Flanders Investment & Trade

Hall map

MEDICA 2018 hall map (Hall 3): stand J74

Fairground map

MEDICA 2018 fairground map: Hall 3

Contact

Dr. Luc Van Hove

CEO

Heirbaan 143
3110 Rotselaar, Belgium

Phone
32476960153

Email
lucvanhove@maracainternational.com

Visit us

Hall 3 / J74

12.11.2018

Topic

Download

all-day

Regulatory, Clinical and Medical consulting services for Medical Device and IVD companies for your CE and FDA registrations

Visit our stand in Hall 3, FIT 3J74 with your questions about the registration in Europe and the USA of your medical devices or in-vitro diagnostic devices. MARACA International can help you prepare for the new Medical Device Regulation and the new IVD Regulation or for the US 21CFR.  We can train you, identify the gaps and help you close these gaps. MARACA can help develop your Design Dossiers or Technical Files. Assist you with your design control, risk management and clinical validation activities. A unique service by our inhouse physician is your design dossier review and Clinical Evaluation Report/Performance Evaluation Report development and sign off. Our physician can help also with your clinical validation studies and Post-Market Clinical Followup studies. As physician he is uniquely positioned to represent and defend you with the NB, CA and FDA.  

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13.11.2018

Topic

Download

all-day

Regulatory, Clinical and Medical consulting services for Medical Device and IVD companies for your CE and FDA registrations

Visit our stand in Hall 3, FIT 3J74 with your questions about the registration in Europe and the USA of your medical devices or in-vitro diagnostic devices. MARACA International can help you prepare for the new Medical Device Regulation and the new IVD Regulation or for the US 21CFR.  We can train you, identify the gaps and help you close these gaps. MARACA can help develop your Design Dossiers or Technical Files. Assist you with your design control, risk management and clinical validation activities. A unique service by our inhouse physician is your design dossier review and Clinical Evaluation Report/Performance Evaluation Report development and sign off. Our physician can help also with your clinical validation studies and Post-Market Clinical Followup studies. As physician he is uniquely positioned to represent and defend you with the NB, CA and FDA.  

More Less

14.11.2018

Topic

Download

all-day

Regulatory, Clinical and Medical consulting services for Medical Device and IVD companies for your CE and FDA registrations

Visit our stand in Hall 3, FIT 3J74 with your questions about the registration in Europe and the USA of your medical devices or in-vitro diagnostic devices. MARACA International can help you prepare for the new Medical Device Regulation and the new IVD Regulation or for the US 21CFR.  We can train you, identify the gaps and help you close these gaps. MARACA can help develop your Design Dossiers or Technical Files. Assist you with your design control, risk management and clinical validation activities. A unique service by our inhouse physician is your design dossier review and Clinical Evaluation Report/Performance Evaluation Report development and sign off. Our physician can help also with your clinical validation studies and Post-Market Clinical Followup studies. As physician he is uniquely positioned to represent and defend you with the NB, CA and FDA.  

More Less

15.11.2018

Topic

Download

all-day

Regulatory, Clinical and Medical consulting services for Medical Device and IVD companies for your CE and FDA registrations

Visit our stand in Hall 3, FIT 3J74 with your questions about the registration in Europe and the USA of your medical devices or in-vitro diagnostic devices. MARACA International can help you prepare for the new Medical Device Regulation and the new IVD Regulation or for the US 21CFR.  We can train you, identify the gaps and help you close these gaps. MARACA can help develop your Design Dossiers or Technical Files. Assist you with your design control, risk management and clinical validation activities. A unique service by our inhouse physician is your design dossier review and Clinical Evaluation Report/Performance Evaluation Report development and sign off. Our physician can help also with your clinical validation studies and Post-Market Clinical Followup studies. As physician he is uniquely positioned to represent and defend you with the NB, CA and FDA.  

More Less

Our range of products

Product categories

  • 07  Medical Services and Publications
  • 07.10  Consulting services for health organisations

Our products

Product category: Other diagnostics, Consulting services for health organisations

Regulatory, Clinicial and Medical Consulting services for your MD and IVD registrations in CE and USA

MARACA International offers a unique service as Medical Practitioner.
This includes:
• Physician input and review of the design of the product
• Advisor in the development of Companion diagnostic products
• Risk management review for patient impact
• Health Hazard assessment of a complaint for patient impact
• Risk-Benefit summary development and signing as Medical Practitioner
• Clinical evidence development from literature review and signing as Medical Practitioner
• Assessment of clinical evidence in the Performance evaluation report
• Clinical performance study protocol development
• On-market clinical study protocol development
• Clinical performance study synopsis as Medical Practitioner
• Statistical analysis plan with endpoints for clinical performance study
• Clinical performance study report writing and signing as Medical Practitioner
• Physician representation with FDA and competent authorities

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