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Medical Device Labeling Changes and Challenges Under EU MDR
Medical Device Labeling Changes and Challenges - EU MDR Implementation of the EU MDR can be complex and challenging.
Components of an Effective Post-Market Surveillance for Medical Devices
Effective Post-Market Surveillance for Medical Devices Post-market surveillance (PMS) is defined as "a systematic process to derive necessary corrective
Taking Advantage of the EU MDR Delay in Uncertain Times – Webinar
Celegence Webinar: Taking advantage of the EU MDR Delay in Uncertain Times What: Webinar in conjunction with RAPS showing
Remote Medical Audits During COVID-19
Remote Medical Audits During COVID-19 The healthcare sector is at the epicenter of the current global pandemic challenge. With
Addressing the Regulatory Challenges with Software as a Medical Device in EU MDR
Guidance on Qualification and Classification of Software as a Medical Device in Regulation (EU) 2017/745 Cutting-edge technology has
Implications of COVID-19 on the Medical Device and Diagnostics Industry
COVID-19 Impact on the Medical Device and Diagnostics Industry The SARS-CoV-2 pandemic and the unprecedented nature of this health
IMDRF & Summary of Recent Changes to Clinical Evaluation Guidance
International Medical Device Regulators Forum (IMDRF) & Summary of Recent Changes to Clinical Evaluation Guidance This blog is aimed
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