The Impact of ISO 14155 on PMCF Investigations Under the MDR
Download this white paper to prepare for the new MDR requirements requiring that PMCF investigations be conducted in compliance with ISO 14155.
Satisfying PMCF requirements by utilizing IIS data
This white paper describes an approach that would enable medical device manufacturers to leverage anonymous data from IIS projects to support the fulfilment of PMCF data requirements.
5 steps to meet PMCF requirements
Read the white paper to learn how Castor’s 5-step approach to PMCF can be used to fulfill MDR requirements.
6 essential steps to ensure Medical Device Regulation (MDR) compliance before May 2020
The impact of the Medical Device Regulation on the medical device industry is substantial as the regulations focus…
Three expected changes to FDA medical device approval in 2019
2019 was an interesting year for medical device companies. In our previous blog articles, we discussed the complete overhaul…
In-Vitro Diagnostic Regulation (IVDR): From oversight to overhead
The rising demand for early, accurate disease diagnosis and the growing possibilities in personalised medicine are driving the…
What does the Medical Device Regulation (MDR) tell us about Post-Market Surveillance?
With the Medical Device Regulation (MDR) coming into full force in 2020, medical device companies should prepare for…
4 ways the Medical Device Regulation (MDR) will impact your device studies
Medical device companies targeting the EU market are being confronted with significant regulatory changes for market access. As…
