clinical evaluation Archives - AKRN

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Articles

May 5, 2021

Does the MDR mean the end of the equivalence route for clinical evaluations?

The concept of equivalence in the European’ MedTech sector In Europe, medical device manufacturers with products on the market have long used

February 3, 2021

CER according to the MDR

MDR Clinical Evaluation: definitions EU Regulation 2017/745, commonly referred to as Medical Device Regulation (MDR), requires the assessment of

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.

The evolution of an AKRNer... From egg 🥚 to eag

The evolution of an AKRNer...
From egg 🥚 to eagle 🦅 ...and now we are flying to a new nest, in a new office, with space for many, many more ...

Two of the smartest girls in Madrid on their way t

Two of the smartest girls in Madrid on their way to save the world 🌎 🧠 💊

Monitoring visit in Leon today for @posapodean and

Monitoring visit in Leon today for @posapodean and @ruben_ruizz 🧠 📖

Mission accomplished!

Mission accomplished!

Shopping day 🛒 with @maria.nyakern and @arigado

Shopping day 🛒 with @maria.nyakern and @arigadoryoga

Our clinical team is at the hospital to monitor th

Our clinical team is at the hospital to monitor the data of a ATMP study. Our clinical team are becoming experts on the regulatory framework for advanced therapy medicinal products (ATMPs). @jorgemedinafd and the CRA team

Planning the next monitoring visit ...

Planning the next monitoring visit ...

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 📑 #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 ...💙 Today Diana gave a short interview related to ISO 14155 and good clinical practice.
#clinicalresearchprofessional

Happy birthday Raquel 🎉 Life is better and more

Happy birthday Raquel 🎉
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 🔥☄️🧨🎇

𝐈𝐧𝐢𝐭𝐢𝐚𝐭𝐢𝐨𝐧 𝐨𝐟

𝐈𝐧𝐢𝐭𝐢𝐚𝐭𝐢𝐨𝐧 𝐨𝐟 𝐚 𝐜𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐭𝐫𝐢𝐚𝐥 𝐢𝐧 𝐒𝐩𝐚𝐢𝐧 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 Española 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 💙

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