Why ÅKRN as Your Medical Device CRO?
We are flexible, agile, and with solid medical device expertise. We offer optimized regulatory and clinical services tailored to our clients and MedTech partners.
Our qualified clinical and medical professionals have the expertise to design and manage studies that demonstrate the safety and performance/efficiency of medical devices and in-vitro diagnostics. We help our clients before and after entering the European market by guaranteeing timely set up of clinical trial activities and establishing efficient research solutions.
Areas of Expertise
ÅKRN works 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.
Perfect Partner for MedTech Companies and Startups
We can meet short turnaround times, which is extremely important for the medical device starts-ups during the development phase, where clinical milestones demonstrate the value of the new technology and guarantee the next round of financing.
As a medical device CRO, we develop clinical studies for all classes of medical devices (Class I, Class II, and Class III) according to the new 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 the new 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.
Trusted and valued adviser
Maria 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 LlewellynCEO HL Healthcare Ltd.
“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 ZwaefGlobal Clinical Operations Manager at LivaNova
Dear 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 WardCEO at Exthera Medical Inc
Great 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-JussenManaging Director at Exthera Medical Europe
I 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 SpaargartenClinical Director at Vimecon Gmbh
Thank 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 WhiteCOO at Exthera Medical Inc
Maria 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 LlewellynPrincipal Consultant ML Pharms Ltd