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Selecting and Working With Your Notified Body for Entering European Market
Notified Bodies (NBs) in the EU Selecting the right Notified Body (NB) can be challenging. Which NB is
Brexit Changes to the Regulatory Process for the Life Sciences Industry
The Impact of Brexit on the Life Sciences Industry As the UK prepares for Brexit following the significant
Medical Devices: Low-Risk Device Challenges MDR
Medical Devices in the EU: Low-Risk Device Challenges The following is the fourth in the series of blogs
Post-Market Clinical Follow-up (PMCF) Requirements under the EU MDR
Post-Market Clinical Follow-up (PMCF) Requirements under the EU MDR The following is the third in the series of blogs
The New European Union MDR: Impact on Technical Files
The New European Union MDR: Impact on Technical Files The following is the second in the series of
Medical Devices: Substantial Equivalence vs. Demonstration of Equivalence
Medical Devices: Substantial Equivalence vs. Demonstration of Equivalence The following is the first in the series of blogs related
Leveraging the Business-Process-as-a-Service (BPaaS) Model in Regulatory Affairs
Leveraging the Business-Process-as-a-Service (BPaaS) Model in Regulatory Affairs The Life Sciences industry has not