December 14, 2022
A literature review is a formal collection of scientific studies published in peer-reviewed journals or conference proceedings that are relevant to the safety evaluation of a medical device product. Literature reviews are essential [...]
August 9, 2022
EU MDR is undoubtedly a fantastic way of upgrading the medical device market quality, but the process is anything but easy. With the slow but [...]
July 26, 2022
While post-market clinical follow-up (PMCF) played a part in the MDD (Directive 93/42/EEC), the updated Medical Device Regulation (MDR, 2017/745) introduced stricter rules for [...]
September 12, 2023
Clinical evaluations for medical devices are long and arduous tasks. But what many medical device manufacturers fail to take into consideration is that clinical evaluations are living processes. They ebb and flow. And [...]
September 5, 2023
You know what is common in all countries? No matter the geographical position, the culture, the people or religion? No one wants medical devices that are unsafe. Seriously, there is literally not one sane [...]
August 29, 2023
Most of us are familiar with clinical evaluations for medical devices. Easy peasy. But when it comes to the equivalent for in vitro diagnostic medical devices, the performance evaluation, most of us are a [...]
August 23, 2023
Navigating the complex regulatory landscape as a medical device manufacturer is pretty difficult. Especially when you have to deal with tons of complex jargon, laws from god knows where, and experts like the notified body [...]
August 21, 2023
By now, most of us have struggled through at least one successful submission for MDR/IVDR, and we know they take time. Very doable, but no ones exactly surprised at home simple everything was to [...]
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 [...]