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ÅKRN IS NOW ISO 9001 QUALITY CERTIFIED

August 24, 2022 by AKRN

Madrid, 24th August 2022 – We are pleased to announce that AKRN, Now part of NAMSA, is now ISO 9001:2015 quality certified by EQA, a recognized Spanish accredited certification body.

Maria Nyåkern, Founder and Executive Director, commented:

“This certification is a testament to AKRN’s commitment to providing high-quality medical device services tailored to our client’s needs. Since the company’s inception, we have always adhered to industry standards, including ISO 14155 GCP for medical devices. The 9001 certification is a milestone for us as a team, and I believe that our operating procedures can guarantee client satisfaction and results that our entire organization can benefit from.”

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.

ISO 9001 AKRN CONSULTING

As a client, you can expect:

  • European Medical Device and IVD expertise
  • Accountability & ownership
  • Optimized services & high responsiveness
  • High compliance with industry standards
  • Businesses continuity
  • Reliable and controlled budgets

AKRN offers clinical, regulatory and quality consulting services for medical devices and in vitro diagnostic medical devices in the European market. Our experience covers a wide range of medical device therapeutic areas, including cardiovascular devices. For more information about our services click here.

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Category iconEuropean Union,  ISO,  IVD,  IVDD,  IVDR,  MDD,  MDR,  Medical Devices,  MedTech,  QMS,  Quality Manangement Systems Tag iconCertified,  CONSULTING,  GCP,  ISO,  ISO 14155,  ISO 9001,  ISO13485,  IVD medical devices,  Medical Devices

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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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Contact email: contact@akrnconsulting.com
Office phone: +34 910 258 140
Office phone: +34 919 333 814
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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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