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Articles – Resources – AKRN Social network


Articles

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

July 24, 2020

European Medical Device Law

Navigating the legal framework for placing Medical Devices (MD) and In Vitro Diagnostic medical devices (IVDs) on the EU market can seem complicated

Category iconIVD,  IVDD,  IVDR,  MDD,  MDR,  Medical Devices,  Medical Technology

July 1, 2020

What are the MEDDEV Guidance Documents?

MEDDEV stands for MEDical DEVices Documents. The MEDDEV Guidance Documents are developed by various working groups on behalf of the European

Category iconDefinition,  MEDDEV,  Medical Devices

July 1, 2020

A Brief Cardiovascular Glossary

Cardiology is a branch of medicine that deals with disorders of the heart and some parts of the circulatory system. Cardiology is concerned with

Category iconCardiovascular,  Definition

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AKRN Social Network


akrn.clinical

Snapshots of life at Γ…KRN 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
Our MDR expert Ariadna Navarro giving us an update Our MDR expert Ariadna Navarro giving us an update on the status of the European regulations πŸ“‘  #clinicalresearchprofessional
At @akrn.clinical you have to be ready to go-live At @akrn.clinical you have to be ready to go-live at any moment ...πŸ’™  Today Diana gave a short interview related to ISO 14155 and good clinical practice. 
#clinicalresearchprofessional
Happy birthday Raquel πŸŽ‰ Life is better and more Happy birthday Raquel πŸŽ‰
Life is better and more beautiful now that you are in it. @rachel.sofia 
Here is a little memory video from your first year at @akrn.clinical πŸ”₯β˜„οΈπŸ§¨πŸŽ‡
𝐈𝐧𝐒𝐭𝐒𝐚𝐭𝐒𝐨𝐧 𝐨𝐟 𝐈𝐧𝐒𝐭𝐒𝐚𝐭𝐒𝐨𝐧 𝐨𝐟 𝐚 𝐜π₯𝐒𝐧𝐒𝐜𝐚π₯ 𝐭𝐫𝐒𝐚π₯ 𝐒𝐧 π’π©πšπ’π§  According to Spanish law, the initiation of a clinical trial in Spain requires two key approvals; one by an authorized EC and the other by the national regulatory authority Agencia EspaΓ±ola de Medicamentos y Productos Sanitarios (AEMPS).  Today our clinical project manager Raquel @rachel.sofia is very happy since she was notified that we have received approval of a very complex study that she and her team have been working on for five months!  #teamwork #clinicaltrials #clinicalresearchassociate
Today we have the pleasure to welcome two new memb Today we have the pleasure to welcome two new members to our business operations and finance team. Alicia @aliciatrg and Mercedes @merce_sbv - welcome to @akrn.clinical πŸ’™
Looking like twins today @arigadoryoga and @robert Looking like twins today @arigadoryoga and @robertoyoga 🌟
We are recruiting πŸ“£ We are looking for clinica We are recruiting πŸ“£  We are looking for clinical evaluation scientists to join our amazing regulatory affairs team under the wings of our manager Ariadna Navarro! @arigadoryoga 
.
Job description and more information on our webpage. Click on link in bio!  #jobposting #empleomadrid
Jorge and Elisa on their way to a monitoring visit Jorge and Elisa on their way to a monitoring visit!
Who are you? β€”β€”β€”β€”β€”β€” #scienceforthepeop Who are you?
β€”β€”β€”β€”β€”β€”
#scienceforthepeople
Sharing workload - and sharing wardrobe..? @posapo Sharing workload - and sharing wardrobe..? @posapodean and @arigadoryoga are on their way to review the status of a clinical investigation at Hospital Puerta de Hierro. πŸ©ΊπŸ’‰πŸ©Έ
β€”β€”β€”
#clinicalresearch
What our team does the best What our team does the best
Always available to guide the team @posapodean πŸ’™
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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 91 113 6635
VAT ID: ES-B87990925

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Latest articles

  • The importance of registering and posting clinical trials in a public database
  • List of Notified Bodies under IVDR (EU) 2017/746 on In-Vitro Diagnostic Medical Devices
  • Literature Search in compliance with MDR
  • 2020 Results: Exceptional Growth
  • Conducting clinical investigations successfully
  • CER according to the MDR

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 aΓ±o 2020. Para ello ha contado con el apoyo del Programa XPANDE DIGITAL de la CΓ‘mara de Comercio de Burgos.
β€œUna manera de hacer Europa”

AKRN Scientific Consulting S.L ha sido beneficiaria de la subvenciΓ³n 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 ConsejerΓ­a de EconomΓ­a, Empleo y Hacienda.

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