Medical Device CRO
We optimize your clinical trials for medical devices and IVD.
Experts in Clinical Research and Regulatory Services for MedTech Industry.
ÅKRN Announces Acquisition by U.S.-Based CRO, NAMSA
New Partnership to Help Meet Growing Demand for Safe and Efficient Clinical Development in Europe
ÅKRN IS NOW ISO 9001 QUALITY CERTIFIED
AKRN, Now part of NAMSA, is now ISO 9001:2015 quality certified by EQA, a recognized Spanish accredited certification body.
European Medical Device CRO
We have solid medical device and in-vitro diagnostics expertise. We offer optimized regulatory and clinical services tailored to our MedTech clients and partners.
Our qualified clinical, medical, and regulatory professionals have the expertise to design, manage and monitor studies that aim to demonstrate the safety, performance, and efficacy of medical devices and in-vitro diagnostics.
We work with Medical Device and IVD companies around the world in the following therapeutic areas.
Our geographic reach extends across Europe, and our experienced team will expertly support your clinical project in all applicable countries.
Dermal Fillers
Perfect Partner for MedTech Companies and Startups
We can meet short turnaround times, which is extremely important for medical device starts-ups during the development phase. We can help you establish clinical milestones that can demonstrate your new technology’s value and guarantee the next round of financing.
As a medical device CRO, we develop clinical studies for all medical device classes (Class I, Class II, and Class III) according to the EU MDR 2017/745. We also design and setup performance studies for in-vitro diagnostic devices (Class A, Class B, Class C, and Class D) under EU IVDR 2017/746.
Our team specializes in medical devices in the cardiovascular therapeutic space, and we aim to be the most experienced and knowledgeable European CRO in this field today.
“We provide unmatched expertise, from initial feasibility trials to market approved products and clinically proven results.”
European Experts on Medical Devices
We are a life-science consulting firm specializing in providing CE-mark strategy and clinical study management for Medical Device and IVD companies. We have skills and insights that are useful at every stage of the project development cycle. We help our clients optimize the management of clinical trials to achieve exceptional efficiency and high regulatory compliance.
Success = Medical Device Expertise + Optimal Design
Our success comes from providing our valued clients with a combination of medical and technical expertise within a tightly controlled budget. Our regulatory work is exclusively focusing on European medical device approvals, and we have developed highly cost-effective and efficient processes to achieve excellent results.
We provide unmatched expertise, from initial feasibility trials to market approved products and clinically proven results. Because of this, our clients and partners view us as a trusted and valued adviser in the clinical trial set up and long term study management.
Testimonials
Trusted and valued adviser
We are grateful for the work delivered by AKRN. The Roadmap provided a clear guide for us to refer too in terms of timelines, costs and steps. The weekly updates were particularly useful for us to follow the project.
Manuel Menéndez
Area specialist of the neurology service at Hospital Universitario Central de Asturias.It has been great to work with AKRN. The whole team has provided an excellent job! We highly appreciate your professionalism and flexibility to adapt to the short delivery time. Thanks for the great job!
Miguel Estruch Soler
Co-Founder at ViromiiIt has been a pleasure to work with the AKRN Clinical Team, they have done a great job
Clinical Development Lead – Ferrer International
Ferrer InternacionalMaria and David, I wanted to thank you for hosting my recent visit in Madrid. I really enjoyed my time and meeting all your staff. Your facilities are truly unique and exceptional...and I mean this in a very positive way....A special thanks to Jorge for all his hard work and exception attention to detail! Please feel free to use me and HL Healthcare as a reference when you need.
Mark Llewellyn
CEO HL Healthcare Ltd.We are very happy with the responsiveness and professionalism of the AKRN team. They have been able to help us with monitoring needs in several countries, securing country approvals for clinical studies, and assisting us with addressing questions from clinical sites and ethics committees. We consider the AKRN team an extension of our own clinical team.
The Clinical Team – Vascular Dynamics Inc.
Vascular Dynamics Inc.The AKRN team provided us with very didactic content in the IVDR training. Thanks for the well-compacted topics.
Adrià Maceira
Co-funder & CEO at CreatSens HealthThe AKRN team has demonstrated unbeatable professionalism, rigor, and efficiency. At Fundación madri+d we are more than satisfied with the support AKRN has provided to several entrepreneurship projects we work with
Xavier Fontcuberta
Project Manager at Fundación para el Conocimiento Madri+dQuisiera agradecerte por las sesiones. Como dijimos fueron sesiones reveladoras. Muchas gracias.
Thais Baleeiro
Jefa de Desarrollo Clínico en Ferrer Internacional S.A.“I would like to thank the AKRN team for your prompt action to submit our study to the authorities in Portugal. We are thankful for your efficient way of working, understanding the customer-needs, and quick turnaround of the project. Congratulations to the entire team!”
Renske De Zwaef
Global Clinical Operations Manager at LivaNovaDear Team! Great news from the CE mark audit! Thanks to everyone who worked hard to get us to this point. This is a very important milestone on the way to commercialization, which is coming soon.
Robert Ward
CEO at Exthera Medical IncGreat appreciation for the work you and your team has done, it has been a great team effort between all parties. Please feel free to give my name as a reference for you and your company.
Carla Kikken-Jussen
Managing Director at Exthera Medical EuropeI am very impressed with the quick turnaround, the very short time your team has done this immense job. It is incredible what has been accomplished in such a short time.
René Spaargarten
Clinical Director at Vimecon GmbhThank you so much for the quick turn around on the IFU. It looks fantastic! Thank you for everything you and the team have done to get us through this CER writing and stage 1 audit processes.
Kathy White
COO at Exthera Medical IncMaria and the team continue to provide our small business with the required expert advice in a cost effective, flexible, efficient, professional and friendly manner. We would highly recommend the services offered by AKRN scientific consulting and we look forward to our ongoing and future collaborations.
Caroline Llewellyn
Principal Consultant ML Pharms Ltd
