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IVD

Articles – Resources – AKRN Social network


Articles

May 20, 2022

Roadmap to CE marking for medical devices and IVDs

Placing medical devices (MD) and in vitro diagnostic medical devices (IVDs) on the market is not an easy and short path. It takes years until the

Category iconCE Mark,  Clinical Investigation,  European Union,  In vitro diagnostic devices,  ISO 14155,  IVD,  IVDD,  IVDR,  MDD,  MDR,  MEDDEV,  Medical Devices,  Notified Body,  Project manager,  Regulatory Affairs,  Uncategorized Tag iconCE marking,  CONSULTING,  ISO 13485,  ISO 14155,  ISO 14971,  ISO 20916,  IVDR,  MARKET ACCESS,  MDR,  Medical device regulation,  Medical Devices,  QMS,  risk,  STANDARD,  STRATEGY

April 29, 2022

The quality management system according to ISO 13485

As a general obligation under the EU regulations, manufacturers pursuing to place medical devices into the EU market shall “establish, document,

Category iconCE Mark,  European Union,  In vitro diagnostic devices,  ISO 14155,  IVD,  IVDD,  IVDR,  MDD,  MDR,  Medical Devices,  Notified Body Tag iconclient,  conformity,  EN ISO 13485,  EU REGULATIONS,  Europe,  ISO 13485,  IVD,  IVDR,  MDR,  medical device,  QMS,  Quality,  quality management system,  safety,  SOP,  Standard operating procedure

November 6, 2021

Impact of MDCG 2021-21 on SARS-CoV-2 IVDs

Recently, the Medical Device Coordination Group (MDCG) has published a new document (MDCG 2021-21) to guide MedTech stakeholders in the performance

Category iconCOVID-19,  In vitro diagnostic devices,  IVD,  IVDD,  IVDR,  Medical Devices

August 19, 2021

PER According to IVDR

Performance Evaluation The EU Regulation 2017/746, commonly referred to as In Vitro Diagnostic Medical Device Regulation (IVDR), imposes

Category iconIVD,  IVDR Tag iconclinical performance,  in vitro,  In vitro diagnostic device,  In vitro diagnostics medical devices (IVDs),  IVDR,  performance evaluation

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

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

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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
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
Bringing a bit of North America to Europe, and Mad Bringing a bit of North America to Europe, and Madrid. 🇺🇸🇪🇺🇪🇸
AKRN is now part of NAMSA 🌎💙 AKRN is now part of NAMSA 🌎💙
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Resources

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

Checkout resources

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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

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Office phone: +34 910 258 140
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Latest articles

  • Summary of Safety and Clinical Performance (SSCP/SSP)
  • Essential documents according to ISO 14155:2020
  • Roadmap to CE marking for medical devices and IVDs
  • The quality management system according to ISO 13485
  • Safety reporting for clinical investigations under the MDR
  • AKRN joins NAMSA – world leading MedTech Contract Research Organization (CRO)

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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