Why ÅKRN as your medical device CRO

Flexible, agile and with the complete medical device expertise. This is how our Medical Device CRO can offer optimized service to our partners.


The expertise of our qualified clinical and medical professionals help our clients to demonstrate the safety and performance/efficiency of medical devices and in-vitro diagnostics before, and after, entering the European market.

We can guarantee timely delivery of clinical trial set up, enabling our partners to be successful in establishing research solutions.

Areas of expertise

ÅKRN works with Medical Device and IVD companies around the world in a very wide range of areas.

Our geographic reach extends across Europe, and our experienced team will expertly support your clinical project in all applicable countries.

Structural Heart

In Vitro Diagnostics (IVD)

Atrial Fibrillation

Ophthalmic

Neuromodulation

Spinal Cord Injuries

Hypertension

Implant and Digital Dentistry

Endocrinology and Diabetes

Critical Care and Sepsis Management

AI/Machine Learning SaMD

Minimally Invasive Surgery

Endovascular Aortic Repair Treatment (EVAR)

Percutaneous Coronary Interventions (PCI)

Transcatheter Aortic Valve Implantation (TAVI)

Neurovascular Mechanical Thrombectomy

Perfect Partner for 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 must be met rapidly to demonstrate the value of promising new technology and to guarantee the next round of financing.

As a medical device CRO, we develop clinical studies for Class I, Class II, and Class III medical devices, according to the new EU MDR 2017/745, as well as for Class A, Class B, Class C, and Class D under the new EU IVDR 2017/746.

In addition, our team has specialized in medical devices in the cardiovascular therapeutic space and we aim to be the most experienced and knowledgeable CRO in the medical device field.

“We can provide unmatched expertise from initial product trials to clinically approved product results.”

European Experts on Medical Devices

We area life-science consulting firm specializing in CE-mark and clinical research management for the Medical Device and IVD industry. We have skills and insights that are useful at every stage of the project development cycle. This allows our clients to optimize the management of clinical trials to achieve the greatest efficiency.

Success: Medical Device Expertise + Optimal Design

Our success is based upon providing our valued clients a combination of medical and technical expertise within tightly controlled budget and clinical trial support. We dedicate ourselves fully to medical device approvals and placement into the market, with the applications of cost-effectiveness and efficiency always in mind.

We can provide unmatched expertise from initial product trials to clinically approved product results, and because of this we are viewed by our clients and partners as a trusted and valued adviser in the clinical trial set up and study management.

Testimonials

Trusted and valued adviser

  • 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.
    R.W.
    CEO
  • 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.
    C.K.
    Managing Director
  • 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.
    R.S.
    Clinical Director
  • Thank you so much for the quick turn around on the IFU. It looks fantastic!
    K.W.
    COO
  • Thank you for everything you and the team have done to get us through this CER writing and stage 1 audit processes.
    K.W.
    COO
  • 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.
    C.L.
    Principal Consultant ML Pharms Ltd
  • Thank you so much for the quick turn around on the IFU. It looks fantastic!
    K.W.
    COO