Articles β Resources β AKRN Social network
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
The quality management system according to ISO 13485
As a general obligation under the EU regulations, manufacturers pursuing to place medical devices into the EU market shall βestablish, document,
AKRN joins NAMSA – world leading MedTech Contract Research Organization (CRO)
Acquisition to Enhance Cardiovascular Expertise and Regional Presence in Europe TOLEDO, OHIO and MADRID, SPAIN β MARCH 21, 2022 NAMSA, a
Performance Studies for SARS-CoV-2 IVD tests
Performance studies for SARS-CoV-2 IVD tests have become a hot topic since the publication of the MDCG 2021-21 and the common list of COVID-19 IVD
Impact of MDCG 2021-21 on SARS-CoV-2 IVDs
Recently, the Medical Device Coordination Group (MDCG) has published a new document (MDCG 2021-21) to guide MedTech stakeholders in the performance
Classification of IVD under the IVDR
In-vitro diagnostics (IVDs) are medical devices to be utilized in vitro to examine examples obtained from the human body to retrieve data about a
European Medical Device Law
Navigating the legal framework for placing Medical Devices (MD) and In Vitro Diagnostic medical devices (IVDs) on the EU market can seem complicated
In Vitro Diagnostic (IVD) devices and European CE Marking
The in vitro diagnostic (IVD) devices sold in the European Union require a CE mark to certify that the device complies with the current European
AKRN Social Network