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Regulatory Affairs

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

March 25, 2022

Safety reporting for clinical investigations under the MDR

Safety reporting is a crucial aspect of a successful clinical investigation for medical devices. In addition to the Good Clinical Practice (GCP),

Category iconClinical Investigation,  Clinical Research Associate,  Clinical Research Institution,  Clinical Trial,  Competent Authority,  Data manager,  Definition,  European Union,  GCP,  Informed,  ISO 14155,  Medical Devices,  Partners,  Project manager,  Regulatory Affairs Tag iconClinical Investigation,  GCP,  ISO 14155,  MDR,  medical device,  SAE,  safety reporting,  serious adverse event,  vigilance

March 21, 2022

AKRN joins NAMSA – world leading MedTech Contract Research Organization (CRO)

Acquisition to Enhance Cardiovascular Expertise and Regional Presence in Europe  TOLEDO, OHIO and MADRID, SPAIN β€” MARCH 21, 2022 NAMSA, a

Category iconCE Mark,  Clinical Evaluation Report,  Clinical Investigation,  Clinical Trial,  In vitro diagnostic devices,  IVDD,  IVDR,  MedTech,  Notified Body,  rapid test,  Regulatory Affairs Tag iconAKRN,  Cardiovascular,  Clinical Investigation,  Clinical Research,  MDR Medical Device Regulations,  NAMSA

March 1, 2022

Performance Studies for SARS-CoV-2 IVD tests

Performance studies for SARS-CoV-2 IVD tests have become a hot topic since the publication of the MDCG 2021-21 and the common list of COVID-19 IVD

Category iconCE Mark,  Clinical Evaluation Report,  Clinical Investigation,  Clinical Trial,  In vitro diagnostic devices,  IVDD,  IVDR,  MedTech,  Notified Body,  rapid test,  Regulatory Affairs Tag iconanalytical performance,  analytical performance studies,  clinical performance,  clinical performance studies,  COVID-19,  COVID-19 tests,  IVD Directive (IVDD),  IVD medical devices,  IVDR,  IVDR; In-Vitro Medical Devices,  IVDs,  Performance studies,  Rapid antigen tests,  Rapid tests,  SARS-CoV-2,  SARS-CoV-2 tests

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

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

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
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 …
.
πŸ§β€β™€οΈπŸ§β€β™€οΈπŸ§β€β™€οΈπŸ§β€β™€οΈπŸ§β€β™€οΈπŸ§β€β™€οΈπŸ§β€β™€οΈπŸ§β€β™€οΈπŸ§β€β™€οΈπŸ§β€β™€οΈπŸ§β€β™€οΈπŸ§β€β™€οΈπŸ§β€β™€οΈπŸ§β€β™€οΈπŸ§β€β™€οΈπŸ§β€β™€οΈπŸ§β€β™€οΈπŸ§β€β™€οΈπŸ§β€β™€οΈπŸ§β€β™€οΈπŸ§β€β™€οΈπŸ§β€β™€οΈπŸ§β€β™€οΈπŸ§β€β™€οΈπŸ§β€β™€οΈπŸ§β€β™€οΈπŸ§β€β™€οΈπŸ§β€β™€οΈπŸ§πŸ§πŸ§πŸ§πŸ§πŸ§πŸ§πŸ§πŸ§πŸ§πŸ§πŸ§πŸ§
.
#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
VAT ID: ES-B87990925

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Office phone: +34 910 258 140
Office phone: +34 911 136 635
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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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