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AKRN Scientific Consulting S.L.

Contact: Maria Nyakern, President CEO / Principal Advisor, AKRN Scientific Consulting S.L.

Specialty:   Devices, IVD

 

AKRN Scientific Consulting is a medical device and in-vitro diagnostic consulting firm that provides clinical research and regulatory services in Europe, according to the new EU MDR and IVDR regulations and relevant ISO standards (14155:2020 and ISO 20916:2019)

AKRN provides guidance on how to navigate the regulatory landscape in Europe, setting up a successful product development program following the new regulations.

AKRN core services are:

-      Clinical Trial Activation: Clinical Strategy, Study Design, Site Selection, Ethics Committee, and Competent Authority Submissions.

-      Clinical Monitoring: Qualification Visits, Site Initiation Visits, Monitoring Visits, Close-Out Visits.

-      Medical Writing: Clinical Investigational Plan (CIP), MDR Technical File, IVDR Technical File, Clinical Evaluation Report (CER), Performance Evaluation Report, Post Market Clinical Follow Up (PMCF), Post Market Surveillance (PMS) Plan, and annual report (PMS/PSUR)

-      Regulatory: CE Mark Strategic Planning, Product classification and registration of devices, Notified Body and EU Competent Authorities Contact.

-      MDR / IVDR Transition

AKRN specializes in providing MedTech expert solutions that balance quality, timelines, and budget using scientifically rigorous methods.

AKRN team is formed by clinical research and regulatory professionals with higher scientific degrees, including Ph.D., PharmD, and Masters in Clinical Research, and are collectively fluent in eight European languages.

 

 

Organization: AKRN Scientific Consulting S.L.

Work Phone: +34 697 77 13 47         

Email:  This email address is being protected from spambots. You need JavaScript enabled to view it.    

Website:      https://akrnconsulting.com/ 

 

Years in Business: since 2015