December 6, 2022
The In Vitro Diagnostic Regulation (IVDR; 2017/746) started its staggered implementation in May 2022. Compared to the In Vitro Diagnostic Directive (IVDD; 98/79/EC), post-market surveillance and vigilance have been given their due in the IVDR; [...]
July 5, 2022
Post-market surveillance is a significant part of any medical device manufacturer's responsibilities, especially since the European Medical Device Regulation (MDR, 2017/745) implementation put an extra [...]
June 28, 2022
The term summary of safety and clinical performance has recently sent the medical manufacturing world into a buzz. The new MDCG 2019 9 update published [...]
August 15, 2023
Medical device literature reviews are mandatory for any clinical evaluation under the EU MDR. More importantly, they are essential for medical device manufacturers looking to establish or confirm their medical devices' benefit/risk profile through clinical [...]
August 8, 2023
In the fast-paced world of healthcare, there are always concerns regarding any new medical device. The concern about cybersecurity in medical devices or, in plainer words, getting hacked or getting your data out on [...]
August 1, 2023
Do you know the crucial part of every medical device clinical evaluation? Yep, you guessed it - the state-of-the-art section! This part might not be the trickiest, but trust me, it comes with its [...]
July 25, 2023
Inflation has been upon us for some time, affecting almost every business, including medical device clinical evaluation and regulatory compliance. Since the cost of living, materials, and services have increased, manufacturers are struggling to meet [...]
July 13, 2023
Getting the long-awaited CE mark is certainly something to celebrate, so if you got it, congratulations! Now you just have to make sure to keep it! While the preparation for the device launch (which [...]
July 4, 2023
Requirements for post-market surveillance (among a host of other requirements for everything from classification to clinical follow-up) were never that elaborate in the In Vitro Diagnostics Directive (IVDD; 98/79/EC). However, with the introduction of [...]
June 27, 2023
A systematic literature review is one of the most important stages of the CER process, but it's also time-consuming and labor-intensive. Literature review software tools make the process a little easier by streamlining the [...]
June 20, 2023
The literature review is a critical part of any clinical evaluation. It's where you collect all of your clinical data, analyze it, weigh it, and use it to evaluate the acceptability of your device's risk-benefit [...]
June 13, 2023
The European Union Medical Device Regulation (EU MDR) is easily one of the major changes in the last decade that altered the medical device sector in the European Union. The goal was to improve [...]