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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
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
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
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
What is the IVDR?
In-vitro medical devices Regulation (IVDR) The in-vitro medical devices Regulation (IVDR) is the new harmonized regulatory framework to ensure
ISO 20916 new international standard for IVDs
Good study practice for clinical evaluation of in-vitro diagnostic medical devices The International Standard for clinical performance studies
ISO 20916 for IVD vs. ISO 14155 for Medical Devices
The ISO 20916 is specific for in-vitro diagnostic (IVD) medical devices The ISO 20916 was released in 2019 and uses definitions and concepts
TCT Congress | San Diego, California
The Transcatheter Cardiovascular Therapeutics (TCT) meeting is the world’s largest educational meeting specializing in interventional cardiovascular
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