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Clinical Research Associate

Articles – Resources – AKRN Social network


Articles

December 14, 2022

Artificial Intelligence challenges in Medical Devices

Artificial intelligence (AI) is constantly bringing improvements to the field of medical devices, with AI technology being embedded in software used

Category iconArtificial Intelligence,  Clinical Investigation,  Clinical Research Associate,  Clinical Research Institution,  Clinical Trial,  Competent Authority,  European Union,  MDR,  Medical Devices,  Medical Technology,  Medical Writer,  MedTech,  Notified Body,  SaMD Tag iconartificial intelligence,  MDR Medical Device Regulations,  Medical device regulation,  Medical Devices,  Performance,  safety

October 24, 2022

AUDITING A QMS ACCORDING TO ISO 13485

When considering obtaining an ISO 13485 certificate, developing and implementing a quality management system (QMS) is not the end of the road. Indeed,

Category iconClinical Data Management,  Clinical Evaluation Report,  Clinical Investigation,  Clinical Research Associate,  Clinical Research Institution,  Competent Authority,  ISO,  ISO:13485,  QMS,  Quality Manangement Systems

March 25, 2022

Safety reporting for clinical investigations under the MDR

Safety reporting is a crucial aspect of a successful clinical investigation for medical devices. In addition to the Good Clinical Practice (GCP),

Category iconClinical Investigation,  Clinical Research Associate,  Clinical Research Institution,  Clinical Trial,  Competent Authority,  Data manager,  Definition,  European Union,  GCP,  Informed,  ISO 14155,  Medical Devices,  Partners,  Project manager,  Regulatory Affairs Tag iconClinical Investigation,  GCP,  ISO 14155,  MDR,  medical device,  SAE,  safety reporting,  serious adverse event,  vigilance

image of Europe flag

October 11, 2021

AKRN as your Contract Research Organization (CRO) in Italy, Spain and Portugal

According to clinicaltrials.gov Europe is home to the second larges number of clinical trials. During the COVID-19 pandemic, the number of clinical

Category iconCE Mark,  Clinical Data Management,  Clinical Investigation,  Clinical Research Associate,  Clinical Trial,  Data manager,  IVDR,  MDR,  Medical Devices,  Medical Technology

October 11, 2021

Seven entry points into clinical research

This article describes seven career paths available to people seeking to break into the field of clinical research. Clinical

Category iconBiostatistician,  CE Mark,  Clinical Data Management,  Clinical Investigation,  Clinical Research Associate,  Clinical Trial,  Data manager,  IVDR,  MDR,  Medical Devices,  Medical Technology,  Medical Writer,  Project manager,  Regulatory Affairs

February 21, 2021

Conducting clinical investigations successfully

Setting up the project team  When setting up a clinical investigation it is critical to assign the responsibilities for managing the clinical

Category iconClinical Investigation,  Clinical Research Associate,  GCP,  ISO 14155,  Medical Devices,  Project manager Tag iconClinical Research,  GCP,  ISO 14155:2020,  Medical Devices

August 4, 2020

What You Need to Know About the New ISO 14155:2020 Standard

New requirements in the ISO 14155 standard for Medical Device Clinical Investigations The ISO 14155:2020 (Clinical investigation of medical devices

Category iconCardiovascular,  CE Mark,  CER,  Clinical Evaluation Report,  Clinical Investigation,  Clinical Research Associate,  Clinical Trial,  European Union,  GCP,  Good Clinical Practice,  In vitro diagnostic devices,  ISO 14155,  IVD,  Literature review,  MDD,  MDR,  Medical Devices,  PMCF,  Structural Heart

AKRN Social Network


akrn.clinical

Snapshots of life at ÅKRN and our team’s travel across the world to ensure safe medical devices and in-vitro diagnostics’ reach doctors and patients.

Life at AKRN Consulting
It’s beginning to look at lot like Christmas 🎄❤️
The program, designed by our founder @maria.nyaker The program, designed by our founder @maria.nyakern has had two champions today... congratulations to @ferpelarda and @jairoruiz_ for this achievement and a significant step within our family #ToghetherWeAreBiggerandBetter.
One year in AKRN♥️♥️ @esmeraldagmz @vio_16 One year in AKRN♥️♥️ @esmeraldagmz @vio_16 @laumcampesino @aranchalp
Izarne and Katharina, regulatory research fellow a Izarne and Katharina, regulatory research fellow and clinical research scientist. 💙
Excursion day with boat tour and snorkeling 🤿 Excursion day with boat tour and snorkeling 🤿
Hector, Iñigo and Alvaro ☀️🕶 Hector, Iñigo and Alvaro ☀️🕶
Popular! @albertnehu 💯 Popular! @albertnehu 💯
The dream business development team. Lucía, Paola The dream business development team. Lucía, Paola, Julián, Stefania and Matías 🗺📈🧪👩🏼‍🔬🧬
Employee number 2, 40, and 3. Employee number 2, 40, and 3.
Quarterly meeting | here some example of the prese Quarterly meeting | here some example of the presentations by @maticach @posapodean and @arigadoryoga
Let’s get going …! Let’s get going …!
Team building anno 2022… . We are more than doub Team building anno 2022…
.
We are more than double compared to last year …
.
🧍‍♀️🧍‍♀️🧍‍♀️🧍‍♀️🧍‍♀️🧍‍♀️🧍‍♀️🧍‍♀️🧍‍♀️🧍‍♀️🧍‍♀️🧍‍♀️🧍‍♀️🧍‍♀️🧍‍♀️🧍‍♀️🧍‍♀️🧍‍♀️🧍‍♀️🧍‍♀️🧍‍♀️🧍‍♀️🧍‍♀️🧍‍♀️🧍‍♀️🧍‍♀️🧍‍♀️🧍‍♀️🧍🧍🧍🧍🧍🧍🧍🧍🧍🧍🧍🧍🧍
.
#mallorca #teambuilding #togetherwearebigger
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Resources

Checkout our selection of resources about medical devices and clinical writing.

Checkout resources

  • Research Websites
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Request a free consultation

Our team will help you to find the best solution for your needs. Our medical device experience and clinical knowledge can help you plan, set up, and execute a clinical trial, or performance study, in an optimal way.

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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

Contact details

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

Content

  • Medical Device Consulting Services
  • Clinical Studies for Medical Devices
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Resources

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Latest articles

  • Artificial Intelligence challenges in Medical Devices
  • What is good clinical practice (GCP)?
  • Drug or Device? Summary and analysis of MDCG 2022-05 on borderline products
  • TRANSITIONAL PROVISIONS according to (EU) 2017/746 ARTICLE 110 IVDR, AN UPDATE WITH MDCGs published in 2022.
  • FELLOW PROGRAM – THE TALENT INCUBATOR OF A CRO
  • AUDITING A QMS ACCORDING TO ISO 13485

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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