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NAMSA AND ÅKRN: PROVIDING FULL CONTINUUM MEDTECH DEVELOPMENT SOLUTIONS

March 27, 2023 by AKRN

TOLEDO, OHIO and MADRID, SPAIN — MARCH 21, 2022

NAMSA, a world leading MedTech Contract Research Organization (CRO) offering global end-to-end development services, announced today its intent to acquire ÅKRN Scientific Consulting, a prominent European Medical Device CRO based in Madrid, Spain.  
 
ÅKRN, founded in 2018, focuses on providing exceptional services to the medical device and diagnostic industries in Europe. Grounded in medicine and science, the organization assists Sponsors move MedTech products from medical discovery into clinical development, commercialization and Post-Market Follow-Up. Known for their expertise in Cardiovascular research, ÅKRN’s Team of Clinical Scientists and Project Managers serve as trusted Client Advisors throughout the complete clinical development process via diligent planning and superior execution.  

“We are thrilled to welcome ÅKRN to NAMSA,” said Dr. Christophe Berthoux, CEO of NAMSA. “The organization is well-respected for their proficiency in European medical device regulations and providing exceptional clinical support to MedTech Sponsors. Adding them to our team will expand our depth of expertise, enabling us to meet the growing demand for safe, efficient clinical development and commercialization of life-changing medical products,” Dr. Berthoux concluded. 

As the global leader in the medical device testing industry since 1967, NAMSA also provides Sponsors support in the areas of regulatory, reimbursement, quality, and clinical research services. NAMSA’s full continuum development services helps Clients overcome development hurdles, mitigate concerns and streamline commercialization efforts. Through proactive planning of varying global regulatory requirements and clinical research obligations, NAMSA’s services are proven to accelerate time-to-market and lower development costs up to 50 percent over industry averages.  

“ÅKRN is a wonderful partner for NAMSA—I feel we have a perfect fit surrounding company values and a team that shares the same drive to provide exceptional service and resources to the medical device and diagnostic industries,” commented Dr. Maria Nyåkern, CEO of ÅKRN. “Our team, strongly grounded in medicine and science, looks forward to partnering with NAMSA as we continue to increase our presence globally and in Europe. With the expanded expertise of our combined organizations, we will serve as the world’s leading CRO for Cardiovascular research services,” Dr. Nyåkern concluded.  
 
The acquisition of ÅKRN increases NAMSA’s global scale, now serving MedTech Clients across 19 locations throughout APAC, Europe, North America and South America.  
 
The price and terms of the intended transaction are undisclosed.  
 
ABOUT NAMSA  
Helping medical device Sponsors improve healthcare since 1967, NAMSA is the world’s leading MedTech Contract Research Organization (CRO) offering global end-to-end development services. Driven by its global regulatory expertise and in-depth therapeutic knowledge, NAMSA is dedicated to accelerating medical device product development, offering only the most proven solutions to move clients’ products through the development lifecycle efficiently and cost-effectively. From medical device testing; regulatory, reimbursement and quality consulting; and clinical research services, NAMSA is the industry’s premier, trusted partner for successful development and commercialization outcomes. 
Web: namsa.com

NAMSA Media Contact  
Leah A. Davidson, MA, MBA, PCM
Sr. Manager, Global Marketing Communications 
Email: ldavidson@namsa.com 
 
ABOUT AKRN 
Grounded in medicine and science, ÅKRN helps Sponsors move from medical discovery into clinical development, commercialization, and Post-Market Follow-Up. ÅKRN offers optimized regulatory and clinical services tailored to MedTech Clients and Partners in a cost-conscious and diligent manner. ÅKRN’s experience covers many medical device therapeutic areas, including cardiovascular devices and In Vitro Diagnostics (IVD). 
Web: akrnconsulting.com 

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Category iconCE Mark,  Clinical Evaluation Report,  Clinical Investigation,  Clinical Trial,  In vitro diagnostic devices,  IVDD,  IVDR,  MedTech,  Notified Body,  rapid test,  Regulatory Affairs Tag iconAKRN,  Cardiovascular,  Clinical Investigation,  Clinical Research,  MDR Medical Device Regulations,  NAMSA

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AKRN Spain

AKRN Scientific Consulting S.L.
Address: Calle de Fuerteventura 4 (office 1.8)
Office Park La Marina
Postal Code: ES-28703 Madrid
Phone: +34 910 25 81 40
VAT ID: ES-B87990925

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AKRN, Now part of NAMSA, is now ISO 9001:2015 quality certified by EQA, a recognized Spanish accredited certification body. The ISO 9001 standard, established by the International Organization for Standardization (ISO), is the quality standard par excellence, and its structure forms the basis for other quality standards such as the medical device quality standard ISO 13485. Implementing ISO 9001:2015 aims to support organizations in enhancing their overall performance and client satisfaction.

AKRN Scientific Consulting S.L ha sido beneficiaria del Fondo Europeo de Desarrollo Regional cuyo objetivo es mejorar la competitividad de las Pymes y gracias al cual ha puesto en marcha un Plan de Marketing Digital Internacional con el objetivo de mejorar su posicionamiento online en mercados exteriores durante el año 2020. Para ello ha contado con el apoyo del Programa XPANDE DIGITAL de la Cámara de Comercio de Burgos.
“Una manera de hacer Europa”

AKRN Scientific Consulting S.L ha sido beneficiaria de la subvención de contratos de trabajo de la Comunidad de Madrid, cofinanciado por el Fondo Social Europeo y la Iniciativa de Empleo Juvenil, en el marco del Programa Operativo de Empleo Juvenil 2014-2020, gestionado por la Consejería de Economía, Empleo y Hacienda.

La empresa (AKRN Scientific Consulting S.L.) es beneficiaria del Programa “la Caixa” Empleo Joven de ayudas para el fomento de la contratación de personas jóvenes. Estas ayudas están cofinanciadas por el Programa Operativo de Empleo Juvenil / Iniciativa de Empleo Juvenil – Fondo Social Europeo y por la Fundación Bancaria “la Caixa”.

 

 

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