December 13, 2022
Writing a clinical evaluation report compliant with the European Medical Device Regulation (MDR; 2017/745) can be challenging. Ever stricter requirements for clinical evidence, data appraisal, and literature search processes have caused many medical [...]
July 19, 2022
Until January 2021, medical devices in the UK were regulated under the European regulatory framework. After Brexit and the withdrawal of the UK from the [...]
July 12, 2022
The MDR is a sweeping reform of medical device regulation in Europe that aims to strengthen safety and quality. Recently, the provisions of Regulation [...]
October 17, 2023
All medical devices have their merit since all of them are used in the medical field. However, the In vitro diagnostic tools are especially essential since medical practitioners use them to identify, treat, and manage [...]
October 10, 2023
One of the new aspects introduced in the European Medical Device Regulation 2017/745 (MDR) is post-market clinical follow-up (PMCF). While PMCF is well-known in the pharmaceutical world, it is a relatively new concept in [...]
October 3, 2023
As a medical writer, one of the biggest weapons in your arsenal is a well-written, well-researched literature review. It is one of the most wonderful documents that can produce a wealth of information when used [...]
September 19, 2023
Being in the regulatory industry is not as cut and dry as most people think. Sure, you do have to read a lot, usually till your eyes bleed, but as soon as you get [...]
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 [...]