Biocompatibility testing

MARACA training on nanotechnology-based medical device biocompatibility testing

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“Nanotechnology-based medical devices require special attention to biocompatibility testing.”

Dr. Luc Van Hove of MARACA International will train the Safe-N-MedTech consortium partners on the regulatory requirements in Europe for biological toxicity testing of nanotechnology-based medical devices. This training is an introduction to the Medical Device Regulation 2017/745 and the REACH Regulation 1907/2006, last amended in 2021, which specify how nanotechnology-based medical devices need to be handled. The training will then introduce the EN ISO 10993 series of harmonized standards. It starts with the review of the current version of EN ISO 10993-01:2020. The focus will be on defining the list of the chemical components of the final product and on developing the biological toxicity risk documentation. Depending on the location and duration of the contact with the patient and on the toxicity of the component a set of biocompatibility tests will have to be performed. For nanotechnology-based medical devices these harmonized standards are applicable. However, due to the nature of the nanomaterials the general information of the standards are not sufficient and specific tests might have to be developed. Hence, special attention needs to be paid to biocompatibility testing for nanotechnology-based medical devices.

Happy Holidays

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MARACA International wishes

our clients and community

a Merry Christmas and a Happy and Healthy 2022.

 

Thank you to all the volunteers who are keeping up with the relentless CORONA waves and continue to booster vaccinate our community. MARACA also supports the efforts of De Warmste Week,  Physicians without borders, Mercy ships, UNICEF, Fight against Cancer, Fight against MS and local nature preservation initiatives to build a better world for us all.

vaccinatiecentrum Rotselaar

MARACA International participates in COVID-19 vaccination in Rotselaar

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Dr. Luc Van Hove from MARACA International participates in the local vaccination campaign in Rotselaar.  “I felt compelled to help our local vaccination effort in Rotselaar to protect my community from the COVID-19 pandemic.  It feels great to be part of this excellent core team of volunteers. The vaccination program and vaccination center are well received by our population. We are expecting to reach a vaccination level of 90% of our people. It is a wonderful experience to be part of this local effort. I’m sure that this effort is strengthening our community sense and will prepare us better for the climate change efforts needed in the future. MARACA International supporting this local vaccination campaign in Rotselaar is an effort well spent”.

Regulatory Roadmap for the EU registration of nanotechnology-based medical devices and IVDs is published by MARACA International for the Safenmt consortium

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Dr. Luc Van Hove of MARACA International developed a regulatory roadmap for NT-based MD.

Luc developed a regulatory roadmap for the EU registration of Nanotechnology (NT)-based medical devices (MD) and IVDs. This roadmap was commissioned by the Safenmt consortium. For NT-based MD and IVD, as for conventional MD and IVD, this regulatory roadmap is the same.  However, for the NT-based MD additional analytical performance characterization, risk management and labeling is required. The report is now used for training of Safenmt consortium partners and will be presented externally at nanotechnology scientific meetings.

The objective is to educate the nanotechnology field on the required steps for developing a nanotechnology-based medical device and IVD in compliance with the MDR and IVDR regulations.

Within the next two weeks two Safenmt trainings will be organized.

A first external presentation of the regulatory roadmap for NT-based MD will be at the NanoMedSpain symposium on 20 May 2021, which has the new MDR as symposium topic.

Another session is planned for the ETPN (Nanomedicine European Technology Platform) conference on 7-9 September 2021 in Switzerland.

join us at event

RAPS 2020 Euro Convergence

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Dr. Luc Van Hove from MARACA International chairs three IVD sessions at the RAPS 2020 Euro Convergence meeting. This is the annual European convergence of regulatory professionals, which was scheduled in Brussels this year, but due to Corona, is converted to a full virtual meeting. Being part of the organizing scientific committee, Luc says “I’m excited about the scientific content of this meeting, you will enjoy it”. “It was a unique experience to move the presentations to this virtual environment”.

IVD Sessions
Luc is chairing “Regulatory hurdles to overcome to introduce nanotechnology-based IVDs and medical devices to the European Market, a Safe-N-MedTech concern”, 27 Oct. at 9:45-10:15 CET. This sessions reviews the regulatory issues and possible solutions to bring nanotechnology-based devices to the European market. The Safenmt consortium will discuss with the audience how to best support such devices to the market using two test cases and Luc will introduce the audience to the hurdles and possible regulatory roadmap for such nanotechnology-based devices.
The next session which is chaired is called “Implementing practices to comply with the IVDR”, 27 Oct. at 13:30-14:30 CET. Dr. Armin Ritzhaupt from the European Medicines Agency (EMA) will present the European Commission’s view on how to implement the new IVDR.
Hearing it directly from the EMA and from industry will stimulate an interesting discussion with the audience.
The last session is “What is sufficient clinical evidence for IVDs in preparation for the IVDR?”, 28 Oct. at 13:30-14:30 CET. Dr. Julien Senac from TUV SUD will represent the Notified Body view and Luc will present the industry perspective. This is a hot topic, which will create a lot of interest and discussion.
After the session presentations there will be a Zoom chat room available to meet the speakers and discuss your personal questions. This will give you the real congress experience.
During the congress there will be also other chat room opportunities to exchange ideas and interact with RAPS members.
As you can see this will be a great meeting to participate in for regulatory professionals.
See you at the 2020 RAPS Euro Convergence.

2020 Global Excellence Award

MARACA CEO interviewed for 2020 Global Excellence Award

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MARACA International received the 2020 Global Excellence Award, recognizing our focus on delivering Service Excellence.

Based in Flemish-Brabant, MARACA International is a consulting firm which provides executive-level services to medical device and pharmaceutical companies and clinical laboratories across the globe. Following MARACA recent success in the 2020 Global Excellence Awards, we got in touch with CEO Luc Van Hove to find out more.
Founded in 2017, MARACA International have focused on providing the best in-class regulatory, quality and clinical services to medical device manufacturers, clinical laboratories, pharmaceutical companies and notified bodies since inception. To start, Luc begins by offering us an insight into the firm’s specialisms and their typical clientele.
“Medical devices placed on the European market must meet the requirements of their respective regulations, so by ensuring the manufacturer has obtained the CE mark label, we are helping them provide the evidence they need to prove of their compliance. With full management of the manufacturer’s regulatory affairs activities, small and medium size manufacturers can outsource all for effective regulatory affairs management. With further hands-on training on specific parts such as risk management, clinical evidence, performance evaluation reports and the composition of technical documentation, we can facilitate your conformity assessment and understanding of the requirements for CE marking.”

“As well as SME pharmaceutical and medical device companies, we are working through our network of contacts to deliver excellence to all. In regards to our client approach, we focus on their bespoke needs, delivering interactive training sessions to help them focus on the practical implementation of their products. Having introduced a series of training modules around the European medical device regulation, our training sessions can be delivered in-class or can be accessed digitally. Collectively, it’s our mission to help bring medical technology, such as nanotechnology, from concept and development through to medical device registration. Working with our international client base we are committed to improving lives through service excellence.”

Working in a thoroughly competitive industry can make life difficult for some companies when it comes to distinguishing themselves from others. However, with more than 20 years’ experience in the field, MARACA International can offer a unique service as a medical practitioner. Luc added “Unlike many of our competitors in the region, we can advise in the development of companion diagnostic products and offer health hazard assessments for patient complaints.”

Currently, the outbreak of COVID19 is having a major impact on the operations of businesses across the globe. In particular, the pandemic has changed the ways in which MARACA are communicating with both clients and staff as Luc further explains. “The ongoing coronavirus crisis has resulted in many businesses working remotely and we are in a similar boat. Conducting virtual meetings is far from ideal but with tools such as Zoom and Microsoft Teams available we have been able to maintain contact with our clients throughout these difficult times.”
Unlike many others, recruitment in the medical and pharmaceutical industries in these current times is vital as we aim to fight coronavirus, as Luc goes on to explain. “We are looking for experts interested in working within our MARACA network, and currently with the coronavirus pandemic we are keen to recruit more faces as we look to play our part in putting a stop to the spread of this disease.”
Finally, Luc comments on the future of MARACA International and the plans in place to ensure the firm remain one of the leading clinical and regulatory affairs consultancies in Europe. “Going forward, we are focused on supporting our clients with innovative approaches as we look to get through the coronavirus outbreak. Furthermore, bringing innovative nanotechnology-based devices in a compliant way to both the European and US markets, will be a key focus of ours.”

MARACA International at MedTech Summit in Brussels

MedTech Summit Brussels June 2019

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MedTech Summit, Brussels, June 2019
Company Services
MARACA International bvba is a Belgian consulting company providing service excellence in Regulatory, Clinical and Medical Affairs services to Medical Device, IVD and pharma companies, clinical laboratories and notified bodies. 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.

Details of contact person
Luc Van Hove is a MD with > 20-yrs’ industrial experience in Medical Devices, IVD, Molecular Diagnostics, clinical studies and product registrations in EU and US. Luc is CEO and Principal Consultant of MARACA International, Belgium, and provides global consulting services for Medical Devices, IVD, CDx development, clinical studies and registrations, servicing pharma, medical device, IVD companies and clinical laboratories. To contact Luc T:+32476960153;
lucvanhove@maracainternational.com or www.maracainternational.com.

 

Safe-N-Medtech consortium starts

Safe-N-Medtech Consortium kickoff

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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 (tamara.oroz@tecnan-nanomat.es)
Scientific Lead: Angel del Pozo, Biopraxis –Keralty (angel.delpozo@keralty.com)
Communication: Anaïs Le Corvec, Aura Costa (info@cebr.net)
MARACA International, Partner for Regulatory and Clinical services, (www.maracainternational.com; lucvanhove@maracainternational.com)

 

 

Atomium Brussels

Inaugural RAPS Regulatory Conference Europe 2019 in Brussels

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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

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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.