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Clinical Trial

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

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 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 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

June 5, 2020

What is a clinical trial?

A clinical trial is any research conducted in humans evaluating the performance and safety of an investigational product. James Lind conducted the

Category iconClinical Trial,  Definition,  GCP,  ISO 14155,  MDR,  Medical Devices,  WHO

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
Some weeks ago we organized our first quarterly me Some weeks ago we organized our first quarterly meeting. It’s was very well organized by the team at the conference hotel, taking into account all safety measurements which were respected by our Spanish colleagues (e.g., wearing mask for the photo shoot). Try and find the three non-Spanish rebels, from Sweden, Chile and Slovenia. 🙃🙈🇸🇪🇨🇱🇸🇮
Today we decided to do some after-office activitie Today we decided to do some after-office activities to enjoy our employee benefits program “Voyager”. Part of this program is a subscription with @andjoy_es and tonight we tried the climbing center @tsunamiclimb that is next to our office. @posapodean @arigadoryoga @rachel.sofia @jorgemedinafd @ruben_ruizz
Site initiation visit in @vallhebroncampus hospita Site initiation visit in @vallhebroncampus hospital today for a #covid19 clinical trial. With the study monitor @elisanisidro in charge, this study will be a success!
This is how happy José Vicente @chevi_insta is wh This is how happy José Vicente @chevi_insta is when we submit a best-in-class clinical evaluation report (CER) for a software medical device.
Congratulations on the remarkable work to the entire regulatory affairs team! 
—————
#software #medicaldevice
Paying close attention to the details 📔
———
#teamakrn
#TBT to our event in November 2020. We thought we #TBT to our event in November 2020. We thought we were many women then, but we are even more now! Five more women to be exact! 
From six different countries, but all sharing the same good heart. 💙
Last 2020 performance review with @almumillans and Last 2020 performance review with @almumillans and @daviztl 💙
What a great duo they are! 
———
#dreamteam
We are hiring! Financial Controller Administrati We are hiring! 
Financial Controller  Administrativo Contable (Madrid)
——
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. 
———
See link in bio!
———
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 —>
—————————
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 🤓..)
————————
#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
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Resources

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

Checkout resources

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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 Spain

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

AKRN Sweden

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

  • 2020 Results: Exceptional Growth February 24, 2021
  • Conducting clinical investigations successfully February 21, 2021
  • CER according to the MDR February 3, 2021
  • Heart Transplantation Clinical Trials in Spain January 14, 2021
  • IVD Clinical Performance Studies January 8, 2021
  • What is the IVDR? December 21, 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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