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European MDR: EUDAMED Database and UDI

Kapstone Medical medical devices MDR Regulation EU European Union EU MDR 16 January 2020

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...

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

European MDR: Post-Market Surveillance

Kapstone Medical FDA medical devices MDR Regulation EU European Union EU MDR Post-Market Surveillance 8 January 2020

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...

EU MDR: How Clinical Evidence Requirements Affect Medical Device Approvals

Kapstone Medical medical devices MDR Regulation EU European Union EU MDR 18 December 2019

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...

European MDR: Product Portfolios and Technical Documentation

Kapstone Medical medical devices Regulatory MDR Regulation EU European Union EU MDR 12 December 2019

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...

European MDR: Notified Bodies

Kapstone Medical medical device legislation medical devices MDR Regulation EU EU MDR 4 December 2019

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...

European MDR: How do we get ready for MDR?

Kapstone Medical medical devices Regulatory MDR Regulation EU European Union 21 November 2019

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

The new Medical Devices Regulation (2017/745/EU), or more commonly referred to as the EU MDR, poses significant challenges to...

What is European MDR and Why It happened, Timelines for Compliance

Kapstone Medical medical devices Product Development Regulatory MDR Regulation EU European Union 13 November 2019

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

The European Parliament passed the Medical Device Regulation (MDR) two years ago and began a three-year transition period in May 2017...

Our Latest regulation-eu

European MDR: EUDAMED Database and UDI

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

European MDR: Post-Market Surveillance

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

EU MDR: How Clinical Evidence Requirements Affect Medical Device Approvals

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

European MDR: Product Portfolios and Technical Documentation

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

European MDR: Notified Bodies

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

European MDR: How do we get ready for MDR?

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

What is European MDR and Why It happened, Timelines for Compliance

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

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Our Latest regulation-eu

European MDR: EUDAMED Database and UDI

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

European MDR: Post-Market Surveillance

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

EU MDR: How Clinical Evidence Requirements Affect Medical Device Approvals

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

European MDR: Product Portfolios and Technical Documentation

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

European MDR: Notified Bodies

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

European MDR: How do we get ready for MDR?

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

What is European MDR and Why It happened, Timelines for Compliance

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

GET TO MARKET

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OUR SOCIAL MEDIA