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AKRN as you Contract Research Organization (CRO) in Italy, Spain and Portugal
Europe may is second largest region by the number of clinical studies conducted according to clinicaltrials.gov. The reasons
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
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
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
Classification of software under MDR and IVDR
Software as a medical device or in-vitro diagnostic device (part I) Over the past years, software has become an essential tool in healthcare
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
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
Conducting clinical investigations successfully
Setting up the project team When setting up a clinical investigation it is critical to assign the responsibilities for managing the clinical
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
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