Quality Blogs
The following dates are important to take note off…
AI-driven predictive models hold enormous potential for the world of rehabilitation…
What if we told you that software can also be an in vitro diagnostic medical device…
Medical Devices without an intended medical purpose are considered to have the same …
We’ll discuss IPL and laser equipment and the changes that have occurred…
The IVDR therefore replaces the IVDD, with new and enhanced rules. What changes…
In Germany, some SaMDs are now acknowledged to be reimbursed for the use…
It is no longer newsworthy: the United Kingdom has left the European Union…
I bet every healthcare technology developer is talking about artificial intelligence (AI)…
In this blog on requirements stemming from the EU MDR and the EU IVDR.…
What if we told you that software can also be an in vitro diagnostic medical device…
Increasingly, software is being used in e.g. diagnosis of an illness or disability…
Increasingly, software is being used in e.g. diagnosis of an illness or disability.…
But what does the overlap between MDR, GDPR and information…
The arrival of the MDR brings changes to the entire medical device market…
With the EU MDR being applicable, all eyes are on the applicability of…
Is it correct to say that organizations with ISO 13485 certification…
The Medical Device Single Audit Program (MDSAP) allows medical…
With the applicability of the Medical Devices Regulation, there is no leaning back for MDD medical devices…
What are the specific rules CMD’s must comply to?…
Do you manufacture facial fillers? You might be developing a medical device…
To date, FDA’s CDRH is responsible for ensuring reasonably safe and effective…
Regulatory requirements for medical device registration vary greatly…
Do you manufacture facial fillers? You might be developing a medical device…
Software is on the rise when it comes to the implementation in health care…
Fraudulent practices such as in the PIP-case must be thwarted by the law…