Safe-N-Medtech consortium starts

Safe-N-Medtech Consortium kickoff

Safe-N-Medtech Consortium kick-off meeting in Bilbao.

The Safe-N-Medtech Consortium initiative kicked off 2-3 May in Bilbao, in a meeting hosted by Osteba, the HTA Unit of the Health Ministry of the Basque Country (Spain) in collaboration with BIOPRAXIS-BIOKERALTY. The project is coordinated by TECNAN (an SME from Navarra, with great experience in Nano products), together with BIOPRAXIS-BIOKERALTY (the research branch of the global health companies Keralty and Praxis).

Safe-N-Medtech is an Open Innovation Test Bed (OITB) initiative from the European Commission, a new and challenging approach towards upscaling the use of nanotechnologies in Europe and abroad. It represents a European investment of 18M€ over 4 years.

More than 50 founding Consortium members, including MARACA International, gathered in Bilbao, coming from 28 entities and from 13 countries to refine the basis of the collaboration, and set the scene for the first years of the Project.

Ambition and strategy

Society and clinical practice pose a growing demand on novel biomaterials, ICT, micro and nanotechnologies for innovative medical devices and in vitro diagnostics (Medical Technologies-MTs). In addition to the challenge of time, the new technologies are subjected to other pressing factors such as qualification, regulation, cost, biocompatibility and the need to be applicable worldwide. In the most recent years it is obvious that nano-enabled MTs can be applied in nearly every medical area, with a major presence and increased importance in cancer, regenerative medicine, advanced therapies, neurology, cardiology, orthopaedics, and dentistry.

SAFE-N-MEDTECH with MARACA International will build an innovative open access platform to offer to companies and reference laboratories, the capabilities, knowhow, networks and regulatory and clinical services required for the development, testing, assessment, upscaling and market exploitation of nanotechnology-based Medical and Diagnosis Devices.

SAFE-N-MEDTECH will offer a multidisciplinary and market oriented innovation approach to SME´s, Healthcare providers and Industries for the translation to the market of MTs, based on a deep understanding and knowledge of the material nanoproperties, their advanced use and applications in MTs and other aspects involved in MTs safety (electric compatibility, electromagnetic properties, etc).

Who s in?

There are 28 partners in Safe-N-Medtech, including MARACA International, a great challenge for management, but a huge opportunity to address all the key challenges to come ahead. Research Institutes, Small and larger companies, Associations, Health Technology Assessment experts, Hospitals and Care centres are amongst the partners, and ensure the project can cover all the relevant aspects of the translation of nano-enabled medical technologies.

What s next?

SAFE-N-MEDTECH starts its journey by ensuring its validity with four test cases. During the first years of the initiative, the partners will develop their services and test them, so that in four years from now, it becomes a self-sustainable and competitive services platform for companies to test and ensure their nano enabled medtechs are safe to use!


For more info on the project:
Coordinator: Tamara Oroz, TECNAN (
Scientific Lead: Angel del Pozo, Biopraxis –Keralty (
Communication: Anaïs Le Corvec, Aura Costa (
MARACA International, Partner for Regulatory and Clinical services, (;



Atomium Brussels

Inaugural RAPS Regulatory Conference Europe 2019 in Brussels

The inaugural Regulatory Affairs Professionals Society (RAPS) annual Regulatory Conference Europe was organized in Brussels, 13-15 May 2019. The next Convention will be held again in Brussels in May 2020.
At this first European Convention more than 300 regulatory professionals participated. MARACA International helped organize a strong European program covering regulatory topics in pharma, medical device and IVDs fields. The European Commission, Competent Authorities and Notified Bodies were well represented. The EU Commission representative gave an update on the roll out of the MDR and the IVDR.
Dr. Luc Van Hove organized a session on SME concerns with the transition of their IVDs to the IVDR. We had an audience of 50 participants and good discussions on what the stuck points are for SME while migrating their IVDs to the new IVDR. Key issues were available notified bodies; How can the equivalency road be used; What is sufficient clinical evidence; How to run a Post-market Performance study.

RAPS Convergence in Vancouver, Canada

Dr. Luc Van Hove from MARACA International participates in the worldwide regulatory professionals’ RAPS convergence in Vancouver, Canada on 1-4 October to discuss the latest advances in regulatory affairs. He will review in particular progress of SME transition efforts to the new MDR. He wil 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 topic. He strongly recommends SMEs to start PMCF studies now to have sufficient clinical data in support of their design dossier.


AI 2018 global excellence award for Recognized Leader in Quality Control Services – Belgium.

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.

Bloom Hotel

Visit MARACA International at MedTech Summit

MARACA International presents its services at the MedTech Summit Meeting on 11-15 June in Brussels at Hotel NH Brussels Bloom. When you have questions about the new MDR or IVDR and the impact on your company, contact Dr. Van Hove at and we’ll get you on the right track.
MARACA International bvba is a Belgian consulting company providing service excellence for Regulatory, Quality, Clinical and Medical Affairs assignments at Medical Device, IVD and pharma companies, clinical laboratories, notified bodies and governmental agencies. These services support your product registrations in Europe under the MDD, IVDD, MDR and IVDR regulations. In the USA, our services support your submissions to the FDA. Our 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.

Atomium Brussels

Visit MARACA at EU MD IIS Meeting in Brussels

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.

MARACA International Presents at RAPS Workshop on the new IVDR and MDR

MARACA International CEO Dr Luc Van Hove has announced he will be making a presentation regarding the in-vitro diagnostics regulation (IVDR) implementation from an in-vitro diagnostics (IVD) company perspective at the RAPS Workshop on IVDR & MDR.
Taking place from 16 May to 17 May in Brussels, Belgium, attendees will gain an understanding of the general safety and performance requirements (GSPR) changes versus the essential requirements (ER), as well as on the transition strategies for the implementation of the IVDR and the medical device regulation (MDR).
The RAPS Workshop is a key opportunity for visitors to learn the practical applications of the new EU regulatory requirements. Regulatory affairs experts will share valuable insights and unique perspectives on how to address the challenges posed by new regulations.
Sessions will include keynote speakers from the European Commission (EC), updates on the competent authority medical devices (CAMD) roadmap, and both MDR and IVDR changes related to clinical expectations, general safety and performance, technical documentation, labelling and post-market requirements.


Visit MARACA at MEDTECH MEETUP in Brussels 22/03/2018

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.

MARACA International invited to attend the RAPS Netherlands Chapter meeting

Dr. Luc Van Hove from MARACA International has been invited to participate in the RAPS Netherlands Chapter meeting, which can only be attended by special invitation only.
Taking place on 9 February 2018 in Arnhem, MARACA International will exchange ideas on the implementation of the new medical device regulations (MDR) and in-vitro diagnostic medical device regulation (IVDR).
In addition, the implementation acts and guidance will be reviewed. As well as the status of the notified body accreditations and transition will be discussed.
Other items of discussion include the future of MEDDEVs and common specifications. How to develop clinical evaluations for products under the MDR and IVDR.  Finally, the post-market surveillance and risk management requirements will be discussed under the new regulations.
There will be a lot of questions and MARACA International will be the first to understand the best answers.

Amstelveen Companion Diognostics RAPS NL Meeting

Companion Diagnostics IVDR implementation

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.