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Medical Devices

Articles – Resources – AKRN Social network


Articles

December 14, 2022

Artificial Intelligence challenges in Medical Devices

Artificial intelligence (AI) is constantly bringing improvements to the field of medical devices, with AI technology being embedded in software used

Category iconArtificial Intelligence,  Clinical Investigation,  Clinical Research Associate,  Clinical Research Institution,  Clinical Trial,  Competent Authority,  European Union,  MDR,  Medical Devices,  Medical Technology,  Medical Writer,  MedTech,  Notified Body,  SaMD Tag iconartificial intelligence,  MDR Medical Device Regulations,  Medical device regulation,  Medical Devices,  Performance,  safety

December 8, 2022

What is good clinical practice (GCP)?

Good clinical practice (GCP) GCP is an international quality standard that governments can transpose into regulations that decide how clinical

Category iconCE Mark,  Clinical Data Management,  Clinical Evaluation Report,  Clinical Investigation,  Clinical Trial,  ISO 14155,  Medical Devices Tag iconClinical Investigation,  Essential Documents,  ISO 14155,  Medical Devices

August 31, 2022

EU MDR risk management requirements: FMEA and ISO 14971 comparison

Historically, medical device manufacturers have frequently used Failure Modes and Effects Analysis (FMEA) to identify possible failures in

Category iconCE Mark,  In vitro diagnostic devices,  ISO,  ISO 14155,  ISO:13485,  IVD,  Medical Devices,  Risk Management Tag iconFMEA,  IEC 60812,  In vitro diagnostic device,  ISO14971,  IVDR,  MDR,  Medical Devices,  Risk Management

August 24, 2022

ÅKRN IS NOW ISO 9001 QUALITY CERTIFIED

Madrid, 24th August 2022 - We are pleased to announce that AKRN, Now part of NAMSA, is now ISO 9001:2015 quality certified by EQA, a recognized

Category iconEuropean Union,  ISO,  IVD,  IVDD,  IVDR,  MDD,  MDR,  Medical Devices,  MedTech,  QMS,  Quality Manangement Systems Tag iconCertified,  CONSULTING,  GCP,  ISO,  ISO 14155,  ISO 9001,  ISO13485,  IVD medical devices,  Medical Devices

July 26, 2022

DEVELOP AND IMPLEMENT YOUR QMS ACCORDING TO ISO 13485

Previously, we published an article introducing the basic concepts, definitions and requirements for Quality Management Systems (QMS) within the

Category iconISO:13485,  Medical Devices,  MedTech,  QMS,  Quality Manangement Systems,  Regulatory Affairs Tag iconISO 13485 Standardisation; SOP; QMS; Quality Management System; Quality Management; Medical device; Safety; Quality; Efficiency; Regulatory; Client; Conformity; Procedures; Requirements,  IVD medical devices,  Medical Devices,  Quality,  quality management system

June 14, 2022

Essential documents according to ISO 14155:2020

A typical consultation we receive at AKRN Scientific Consulting is related to the essential documents required for planning, conducting and closing

Category iconCE Mark,  Clinical Data Management,  Clinical Evaluation Report,  Clinical Investigation,  Clinical Trial,  ISO 14155,  Medical Devices Tag iconClinical Investigation,  Essential Documents,  ISO 14155,  Medical Devices

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

June 17, 2021

What are the requirements for a clinical evaluation for legacy and well-established technology devices?

Following the publication of the MEDDEV 2.7-1 in 2016 rev 4 and subsequently Medical Device Regulation 2017/745 (MDR), medical device manufacturers

Category iconClinical Investigation,  MDR,  Medical Devices,  MedTech Tag iconAIMDD,  CE-mark,  clinical data,  clinical evaluation,  clinical evidence,  Legacy devices,  MDCG 2020-6,  MDD,  MDR,  Medical Devices,  well-established technology,  WET

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

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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
It’s beginning to look at lot like Christmas 🎄❤️
The program, designed by our founder @maria.nyaker The program, designed by our founder @maria.nyakern has had two champions today... congratulations to @ferpelarda and @jairoruiz_ for this achievement and a significant step within our family #ToghetherWeAreBiggerandBetter.
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
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Resources

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

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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 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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Contact email: contact@akrnconsulting.com
Office phone: +34 910 258 140
Office phone: +34 919 333 814
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Latest articles

  • Artificial Intelligence challenges in Medical Devices
  • What is good clinical practice (GCP)?
  • Drug or Device? Summary and analysis of MDCG 2022-05 on borderline products
  • TRANSITIONAL PROVISIONS according to (EU) 2017/746 ARTICLE 110 IVDR, AN UPDATE WITH MDCGs published in 2022.
  • FELLOW PROGRAM – THE TALENT INCUBATOR OF A CRO
  • AUDITING A QMS ACCORDING TO ISO 13485

AKRN, Now part of NAMSA, is now ISO 9001:2015 quality certified by EQA, a recognized Spanish accredited certification body. The ISO 9001 standard, established by the International Organization for Standardization (ISO), is the quality standard par excellence, and its structure forms the basis for other quality standards such as the medical device quality standard ISO 13485. Implementing ISO 9001:2015 aims to support organizations in enhancing their overall performance and client satisfaction.

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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