EU-MDR-Series-Part-7-Kapstone-Medical

European MDR: EUDAMED Database and UDI

Part 7 in a 7-part series on the EU’s Medical Device Regulation

The European Database for Medical Devices (EUDAMED) was conceived 20 years ago in 1998, originally as part of the In Vitro...

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EU-MDR-Post-Market-Surveillance-Kapstone-Medical

European MDR: Post-Market Surveillance

Part 6 in a 7-part series on the EU’s Medical Device Regulation

The new EU Medical Device Regulation (MDR) builds on the framework of the MDD with an increased emphasis on post-market surveillance...

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EU MDR: How Clinical Evidence Requirements Affect Medical Device Approvals

Part 5 in a 7-part series on the EU’s Medical Device Regulation

Among the significant changes facing device makers transitioning their products in the European Union from the Medical Device...

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European MDR: Product Portfolios and Technical Documentation

Part 4 in our 7-part series on meeting the new requirements under the EU MDR

Complying with the European Union’s Medical Device Regulation (MDR) poses a daunting task for medical device makers...

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European MDR: Notified Bodies

Part 3 in our 7-part series on meeting the new requirements under the EU MDR

If you are new to obtaining marketing approval in the European Union, the concept of Notified Bodies is one of the most...

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