clinical evaluation Archives - AKRN

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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

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.

This is how we end 2021…Let the party begin ….

This is how we end 2021…Let the party begin ….🥳

The winners of this years AKRN Christmas quiz @mat

The winners of this years AKRN Christmas quiz @maticach @beatrizrodriguez.not @ruben_ruizz @hectorfernandezcaro

𝐓𝐡𝐞 𝐰𝐨𝐫𝐥𝐝’𝐬 𝐟𝐢𝐫𝐬𝐭 𝐢𝐧-𝐡𝐞𝐚𝐫𝐭 𝐦𝐢𝐜𝐫𝐨𝐜𝐨𝐦𝐩𝐮𝐭𝐞𝐫 Our clinical team supporting Vectorious Medical Technologies during their first implantation today! Our director of clinical affairs @posapodean clinical research scientist @lugarciai got into green scrubs and enjoyed the experience 💚 #medicaldevice #clinicalresearch

Clinical site visits in Valencia with @inimarquet

Clinical site visits in Valencia with @inimarquet and @hectorfernandezcaro

𝐓𝐫𝐮𝐞 𝐥𝐞𝐚𝐝𝐞𝐫𝐬 𝐜

𝐓𝐫𝐮𝐞 𝐥𝐞𝐚𝐝𝐞𝐫𝐬 𝐜𝐫𝐞𝐚𝐭𝐞 𝐦𝐨𝐫𝐞 𝐥𝐞𝐚𝐝𝐞𝐫𝐬, 𝐧𝐨𝐭 𝐦𝐨𝐫𝐞 𝐟𝐨𝐥𝐥𝐨𝐰𝐞𝐫𝐬 Our team is growing and we need leaders who add value to our people and our organization. We are so happy to promote Raquel Sofia Cordeiro, PhD, @rachel.sofia
Jorge Medina PharmD. @jorgemedinafd and Ruben Ruiz, M.Sc., @ruben_ruizz to managers of our clinical affairs department. They will lead a team of 12 scientists and CRAs. We know Raquel, Jorge, and Ruben as leaders who work for the benefit of others, who inspire and motivate, and who follow a moral compass that always points in the right direction regardless of what happens around them. At AKRN we believe that people grow into the finest version of themselves when you nurture a spirit of compassion and empathy. We always work under the premise that the function of true leadership is to produce more leaders, not more followers. We are certain that this beautiful trio will do an awesome job at creating more confident, trustworthy, and loving leaders. Congratulations on your promotion. You have done an amazing job during the last 3 years and we are so grateful for your contribution #clinicalprojectmanagement #clinicalrresearch #togetherwearwbiggrr

It is with a deep sense of pride and happiness tha

It is with a deep sense of pride and happiness that I promote Diana Posa Podean @posapodean and Ariadna Navarro Aragall @arigadoryoga to associate directors at ÅKRN Scientific Consulting. They have both been part of building the foundation of our company, and their unshakable commitment to our company’s success and dedication to the team has been a cornerstone in our continued growth and consolidation in the European market. I have never met two more multitalented individuals than these two brilliant women. They are carefully bold. They are detailed, but easily paint out the big picture. They are balanced and planned, but lead with a curious intellect and always give room for intuition to change things at the last minute if needed. When one is chosen and given the chance to allow for life’s creativity and light flow, you are also left with a responsibility and duty to pass it forward. Diana and Ariadna, this is not the end. You are both the beginning. In 2040 you will be my age. You will be living in a very different time and with different challenges. Some of which we can’t even imagine today. But you will have the tools, the skills, the intellect, and the heart to find the way forward and guide others to find their purpose, to feel safe, to be successful, and ultimately, to be happy. Congratulations on your promotion! I wish you a life full of love and happiness. @maria.nyakern

“Promotion party” followed by Halloween party

“Promotion party” followed by Halloween party with karaoke 🎤 #togtherwearebigger

We are growing … and it’s time for a new “gr

We are growing … and it’s time for a new “group of six” … #togetherwearebigger

Just a regular day in “Paradise”….😉🧠 @

Just a regular day in “Paradise”….😉🧠 @ruben_ruizz @posapodean @jorgemedinafd @alejando.noname

It can’t get much better than this… getting a

It can’t get much better than this… getting a “hands on” CRA monitoring training by our in-house expert @elisanisidro

Life is full of welcomes and goodbyes … It’s

Life is full of welcomes and goodbyes … It’s rewarding and with great pride that we see Sofia @soflflf spread her wings (literally) and fly towards new adventures ✈️

Recording today 🎥 I don’t need a script anymo

Recording today 🎥 I don’t need a script anymore …
. “Our regulatory experts can help you obtain CE Marking for your medical device and start selling your product in the EU…”
#medicaldevice #clinicalresearchprofessional #clinicalresearchassociate

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