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Tag: medical device regulation

MDR Extension Timeline for Implementation

Medical Devices
The extension of MDR implementation timeline has now become reality. On March 20, 2023, the Regulation (EU) 2023/607, which amends the Medical Device Regulation...

MDR Extension According to Regulation 2023/607

Medical Devices
The extension of MDR implementation timeline has now become reality. On March 20, 2023, the Regulation (EU) 2023/607, which amends the Medical Device Regulation...

Integer Holdings Corporation Reports Second Quarter 2023 Results | BioSpace

Medical Devices
Continued strong performance with 2Q23 financial results Increasing full year 2023 outlook PLANO, Texas, July 27, 2023 (GLOBE NEWSWIRE) -- Integer Holdings Corporation...

3 Absolute Essentials of IVDR Implementation: A Closer Look at the Biggest Changes | Avania

Clinical Trials
The transition from the In Vitro Diagnostic Medical Device Directive (IVDD) to the In Vitro Diagnostic Medical Device Regulation (IVDR) is not something...

Identifying and Evaluating Medical Device Importers

Medical Devices
Expanding into new foreign markets is an exciting chapter for any medical device manufacturer. However, it can also be pretty intimidating.  Each market is a unique...

RegDesk’s AI is Revolutionizing Regulatory Compliance for MedTech Industry | RegDesk

Medical Devices
Technology has the power to streamline redundant processes. Then, why does regulatory compliance for medical technology and devices...

Reflecting on the Second Anniversary of the EU Medical Device Regulation

Medical Devices
As we reach the second anniversary of the date of application of the EU’s MDR, it’s an excellent opportunity to reflect on the journey...

BD Reports Second Quarter Fiscal 2023 Financial Results

Medical Devices
BD 2025 Strategic Investments Driving Growth and Advancing Innovation; Company Raises Mid-point of Revenue and Adjusted EPS Guidance Ranges Revenue of $4.8 billion...

e-IFU requirements translated for implantable medical devices

Medical Devices
<!----> At least for those manufacturers that struggled for a long time printing Instructions for Use (IFU’s) without...

Is EU MDR harming medical device innovation?

Medical Devices
<!----> The extensive technical documentation requirements of the EU’s Medical Device Regulation (EU MDR) are curbing opportunities for...

NHRA Guidance on Medical Device Importation: Process

Medical Devices
The new article describes in detail the process of applying for importation approval for a medical device. ...

EU MDR transitional period extension: More time to certify medical devices

Medical Devices
The Council of the European Commission concluded in a meeting on December 9th to address member states’ concerns...
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