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Global Registration Consulting for Medical Devices and IVDs

Commercializing your medical device first requires you to obtain registration and approval from regulatory agencies in each country where you plan to sell your device.

Clinical Evaluation Reports (CER) for Medical Devices

This webinar provides an overview of manufacturer responsibilities for clinical evaluation under the MDR. The scrutiny of clinical evaluations by Notified Bodies has increased with the EU Medical Devices Regulation 2017/745 (MDR).

2022 Outlook – Updates for Europe’s Regulatory Landscape: Recent Changes in the EU, United Kingdom and Switzerland

Watch this webinar to learn the anticipated updates to the EU IVDR 2017/746 and EU MDR 2017/745, what to look out for from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) and the next steps for Switzerland.

2022 Outlook and Updates for the US Food and Drug Administration

Review recently released and expected guidance documents from the US FDA, the growing use of real-world evidence and regulatory science tools in submissions, and expectations for 2022 and beyond.

Performance Evaluation – When, What and How to Prepare for EU IVDR

This webinar explains the Performance Evaluation concept introduced by IVDR 2017/746 and focuses on the interaction of elements required for manufacturers to perform an adequate Performance Evaluation.

Thomas Huang - Taiwan

Giselle Zhang - China

Luana Zerafa - United Kingdom

Luiz Levy - Brazil

DaYeon Choi - South Korea