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Articles – Resources – AKRN Social network


Articles

January 14, 2021

Heart Transplantation Clinical Trials in Spain

Heart transplantation: aetiology and history Heart transplantation is the surgical replacement of a diseased, failing heart with a compatible and

Category iconClinical Trial,  ISO 14155,  Medical Technology Tag iconhistory,  legislation,  transplantation

January 8, 2021

IVD Clinical Performance Studies

IVD Clinical Performance Studies Before commencing a clinical performance study, the sponsor shall determine and consider the requirements for

Category iconCompetent Authority,  IVD,  Notified Body Tag iconclinical performance,  in vitro,  protocol

December 21, 2020

What is the IVDR?

In-vitro medical devices Regulation (IVDR) The in-vitro medical devices Regulation (IVDR) is the new harmonized regulatory framework to ensure

Category iconCE Mark,  Clinical Trial,  European Union,  ISO 14155,  IVD,  IVDR,  Uncategorized Tag iconCE mark,  IVDR,  IVDs,  Medical Devices

December 17, 2020

ISO 20916 new international standard for IVDs

Good study practice for clinical evaluation of in-vitro diagnostic medical devices The International Standard for clinical performance studies

Category iconCE Mark,  Clinical Trial,  European Union,  ISO 14155,  IVD,  IVDR,  Uncategorized Tag iconCE mark,  IVDR,  IVDs,  Medical Devices

December 17, 2020

ISO 20916 for IVD vs. ISO 14155 for Medical Devices

The ISO 20916 is specific for in-vitro diagnostic (IVD) medical devices The ISO 20916 was released in 2019 and uses definitions and concepts

Category iconCE Mark,  Clinical Trial,  European Union,  ISO 14155,  IVD,  IVDR,  Uncategorized Tag iconCE mark,  IVDR,  IVDs,  Medical Devices

November 27, 2020

Dermal fillers as medical devices under the MDR

Introduction to dermal fillers Dermal fillers are injectable soft tissue substances used in aesthetics to improve skin appearance and minimize

Category iconMDR,  Medical Devices,  Uncategorized

November 24, 2020

Collaboration with the Master in Therapeutic Targets

The University of Alcala was founded in 1499 and is one of the oldest universities in Europe. Several distinguished members of the Spanish culture

Category iconClinical Trial,  GCP,  Partners

August 27, 2020

Classification of IVD under the IVDR

In-vitro diagnostics (IVDs) are medical devices to be utilized in vitro to examine examples obtained from the human body to retrieve data about a

Category iconIn vitro diagnostic devices,  IVD,  IVDD,  IVDR,  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 iconClinical Trial,  ISO 14155,  MDD,  MDR,  Medical Devices

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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
Last 2020 performance review with @almumillans and Last 2020 performance review with @almumillans and @daviztl 💙
What a great duo they are! 
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#dreamteam
We are hiring! Financial Controller Administrati We are hiring! 
Financial Controller  Administrativo Contable (Madrid)
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Formando parte del departamento de administración financiero de nuestra empresa en el sector de salud y productos sanitarios, tus funciones principales será la gestión del proceso completo de facturación de la compañía. 
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See link in bio!
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Requisitos del puesto:
• Formación de Grado Medio o Grado Superior en Administración o Finanzas
• Experiencia en contabilidad e interpretación de balances
• Dominio de Microsoft Office
• Persona con iniciativa, discreción, comprometida y responsable
• Competencia para trabajar en equipo y capacidad de adaptación
.
.
Formación: Formación universitaria FP rama económico-financiera, ciencias empresariales, ADE o similar.
Idiomas: Español y Inglés nivel alto
———————
#joboffer #ofertadeempleo
Before and after...swipe left —> ————— Before and after...swipe left —>
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8:30 am Tired because of a demanding site initiation visit yesterday...
8:45 am Ariadna is already in scrubs and ready to be part of a heart transplant surgery. (In pig 🐷 but anyway 🤓..)
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#clinicalresearchassociate #clinicalprojectmanager #clinicalresearch
We hope that you will be enjoying this holiday sea We hope that you will be enjoying this holiday season as much we are planning to do. It has been a very demanding year for everyone. This holiday we hope to spend meaningful time with close family and friends, and we are preparing to close our offices for the season. 
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We hope you will enjoy the holiday festivities 🥳🎁🎄
📍Zaragoza Site qualification today for a new p 📍Zaragoza 
Site qualification today for a new pharma study @posapodean and @ruben_ruizz
Deep thoughts... 💭 Perhaps planning our next t Deep thoughts... 💭 
Perhaps planning our next team building in Ibiza? @almumillans
Building airplanes or building trial master files. Building airplanes or building trial master files.... as long as we do it together “everything will be alright!” 
@amaliameseguer @posapodean @maria.nyakern @arigadoryoga
From Porto, with love 💙. Have a great day girls From Porto, with love 💙.
Have a great day girls! You will be smashing! 
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#clinicalresearchscientist
Preparing for a site initiation visit (SIV) for a Preparing for a site initiation visit (SIV) for a really groundbreaking device that could have a great impact on organ transplantation and transportation. Ariadna was there today to discuss with the principal investigator and the study team. We are so excited to be part of this new project and clinical study! @arigadoryoga 
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#clinicalresearch #medicaldevices #clinicalresearchassociate
Diana and Raquel on their way to Porto (Portugal) Diana and Raquel on their way to Porto (Portugal) to qualify a clinical site for a new and exciting pharm trial. Since Raquel is Portuguese we expect that tonight she will show Diana the delicias of Portugal and probably have a nice glass of “Verdelho”? @posapodean @rachel.sofia 
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#clinicalresearchassociate #clinicaltrialsguru #clinicalresearch
“Reliability” is a measure of stability and co “Reliability” is a measure of stability and consistency. Perhaps it is one of the most important traits in any relationship?Thank you @daviztl for all that you do everyday for all of us at @akrn.clinical 💙🦋
One week ago today... Our @arigadoryoga took the s One week ago today... Our @arigadoryoga took the steps towards married life and we were all there to celebrate with her 🦋💙
.
#togetherwearebetter
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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 Scientific Consulting S.L.
Address: Calle Cristo de los Remedios 2
Postal Code: ES-28703 Madrid
Phone: +34 6 9777 13 47
VAT ID: ES-B87990925

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AKRN Scientific Consulting A.B.
Address: Tytterövägen 26
Postal Code: SE-82595 Hudiksvall
Phone: +46 8 4373 74 93
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Latest articles

  • Heart Transplantation Clinical Trials in Spain January 14, 2021
  • IVD Clinical Performance Studies January 8, 2021
  • What is the IVDR? December 21, 2020
  • ISO 20916 new international standard for IVDs December 17, 2020
  • ISO 20916 for IVD vs. ISO 14155 for Medical Devices December 17, 2020
  • Dermal fillers as medical devices under the MDR November 27, 2020

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.
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