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Regulatory Challenges in Writing EU MDR Compliant Clinical Evaluation Reports (CERs)
Regulatory Challenges in Writing EU MDR Compliant Clinical Evaluation Reports (CERs): What the Changes Could Mean for Your
FDA Medical Device Registrations – 510(k) Submissions
FDA Medical Device Registrations - 510(k) Submissions Medical device manufacturers in the US can bring their products to market
Medical Devices with Ancillary Medicinal Substances (Combination Products)
Medical Devices with Ancillary Medicinal Substances - EU MDR The following is the sixth in the series of blogs
Regulatory Intelligence – Making Contextual Sense of the Flood of Data
Regulatory Affairs Planning - Finding The Quality Data The life sciences industry is awash with data from both internal
EU MDR Checklist – Key Timelines & Impact on Medical Device Companies
EU MDR Checklist Download - Get Actionable Technical Documentation Requirements The European Medical Device Regulation (EU MDR) guarantees
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