September 20, 2022
The research process is often thought of as a linear, straightforward path. You begin with a question and then proceed to find the answer. But, in reality, research is a messy process that often involves [...]
December 24, 2021
Healthcare is undergoing a paradigm shift as cutting-edge technology makes its way into medical devices, tele-health, and digital health solutions. Most modern medical devices are manufactured with integrated software and software in general has become [...]
October 7, 2021
In accordance with the European directive for medical devices 93/42/EEC, ‘manufacturers must provide proof of and document the performance and safety of medical devices in a "clinical evaluation"’. With the breast implant scandal in [...]
August 31, 2021
The MDR forces manufacturers to set up processes for continuous literature reviews and reevaluation of the available clinical data. In May 2021, the European Medical Device Directive (93/42/EEC) was replaced with the Medical Device [...]
April 19, 2021
Breaking Down EU MDR Implementation for Class 1 Medical Devices Breaking Down EU MDR Implementation for Class 1 Medical Devices Following the one-year delay in the MDR Date of Application, the Class I [...]
March 12, 2021
All MedTech companies face increased post-market surveillance (PMS) requirements under the EU MDR and IVDR. A PMS plan will incorporate a Post-Market Clinical Follow-up (PMCF) plan or justification for why it is unnecessary. [...]
March 9, 2021
Introduction to Software as a Medical Device in MDR The MDCG's Guidance document defines the criteria for software qualification falling within the scope of the EU MDR and IVDR. This article seeks to [...]
January 27, 2021
Looking For A World Class CER Writer for your EU MDR Submission? EU MDR has certainly made things more difficult for manufacturers seeking the CE mark, especially in regard to Clinical Evaluation. If you [...]
December 14, 2020
With ongoing negotiations over a trade deal between the UK and the EU and less than 30 days until the end of the Brexit transition period, the UK Government continues to flesh out guidance [...]
November 26, 2020
What the Medicines and Healthcare Products Regulatory Agency Does? MHRA is an executive agency in the Department of Health and Social Care. The Medicine and Healthcare products Regulatory Agency regulates medicines and devices for [...]