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Medical Technology

Articles – Resources – AKRN Social network


Articles

February 21, 2022

Progressive roll-out of the IVDR: extended timelines for certain IVDs

By the end of 2021, the European Parliament adopted the proposal of the European Commission to amend the EU 2017/746 in vitro diagnostic medical

Category iconCE Mark,  European Union,  In vitro diagnostic devices,  IVDR,  Medical Technology,  MedTech,  Notified Body,  Regulatory Affairs Tag iconArticle 110,  EU IVD regulation 2016/746 (IVDR),  Extension period,  In vitro diagnostics medical devices (IVDs),  IVDD transition,  IVDR,  Legacy devices,  notified bodies under IVDR,  Notified body

December 17, 2021

How to set up agreements to conduct a clinical investigation?

Everyone involved in clinical research must follow Good Clinical Practice (GCP) as specified in ICH GCP and the international ISO standard 14155:2020,

Category iconCE Mark,  CEIC,  Clinical Investigation,  Clinical Trial,  CTA,  GCP,  Informed,  ISO 14155,  IVDR,  MDR,  Medical Devices,  Medical Technology,  Portugal

November 17, 2021

How to conduct a clinical investigation of medical devices in Portugal

Clinical investigations with medical devices should be performed by health care professionals with scientific and medical qualifications and

Category iconCE Mark,  CEIC,  Clinical Investigation,  Clinical Trial,  GCP,  Informed,  ISO 14155,  IVDR,  MDR,  Medical Devices,  Medical Technology,  Portugal

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

October 11, 2021

What is CE marking and do all products need CE marking?

Not all products sold in the European Union (EU) need to bear CE marking. CE marking is only mandatory for those products that fall under

Category iconCE Mark,  European Union,  IVDR,  MDR,  Medical Devices,  Medical Technology,  Notified Body

February 24, 2021

2020 Results: Exceptional Growth

Excellent Team and Strong Operational Performance  We ended 2020 with significant momentum, which is expected to continue in 2021 with a

Category iconCE Mark,  Clinical Investigation,  GCP,  ISO 14155,  MDR,  Medical Devices,  Medical Technology Tag iconClinical Research,  GCP,  ISO 14155:2020,  Medical Devices

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

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

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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
Izarne and Katharina, regulatory research fellow a Izarne and Katharina, regulatory research fellow and clinical research scientist. πŸ’™
Hector, IΓ±igo and Alvaro β˜€οΈπŸ•Ά Hector, IΓ±igo and Alvaro β˜€οΈπŸ•Ά
Popular! @albertnehu πŸ’― Popular! @albertnehu πŸ’―
The dream business development team. LucΓ­a, Paola The dream business development team. LucΓ­a, Paola, JuliΓ‘n, Stefania and MatΓ­as πŸ—ΊπŸ“ˆπŸ§ͺπŸ‘©πŸΌβ€πŸ”¬πŸ§¬
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
Team building anno 2022… . We are more than doub Team building anno 2022…
.
We are more than double compared to last year …
.
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.
#mallorca #teambuilding #togetherwearebigger
Bringing a bit of North America to Europe, and Mad Bringing a bit of North America to Europe, and Madrid. πŸ‡ΊπŸ‡ΈπŸ‡ͺπŸ‡ΊπŸ‡ͺπŸ‡Έ
AKRN is now part of NAMSA πŸŒŽπŸ’™ AKRN is now part of NAMSA πŸŒŽπŸ’™
Manager couch @rachel.sofia @elisanisidro @ruben_r Manager couch @rachel.sofia @elisanisidro @ruben_ruizz
Happy hour on Thursday at @akrn.clinical πŸ’™πŸ»πŸ‘Ύ
Same, similar or equivalent? Same, similar or equivalent?
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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
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Latest articles

  • 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)
  • Performance Studies for SARS-CoV-2 IVD tests
  • Progressive roll-out of the IVDR: extended timelines for certain IVDs

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.

La empresa (AKRN Scientific Consulting S.L.) es beneficiaria del Programa “la Caixa” Empleo Joven de ayudas para el fomento de la contrataciΓ³n de personas jΓ³venes. Estas ayudas estΓ‘n cofinanciadas por el Programa Operativo de Empleo Juvenil / Iniciativa de Empleo Juvenil – Fondo Social Europeo y por la FundaciΓ³n Bancaria “la Caixa”.

 

 

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