Tag: medical device regulations

Similarities and Differences between Medical Device 510(k) and CE Marking

Medical Devices March 1, 2024

This article highlights some of the similarities and differences between the Medical Device 510(k) and CE Marking regulatory pathways and helps harmonise some aspects...

MDA Guidance on Medical Device Grouping: Overview | MDA

Medical Devices February 29, 2024

Integer Holdings Corporation Reports Results for Fourth Quarter and Full Year 2023 | BioSpace

Medical Devices February 14, 2024

Hologic Announces Preliminary Revenue Results for First Quarter of Fiscal 2024

Fintech January 7, 2024

RF Medical Completed the Transition to European Medical Device Regulations (MDR) for Class IIb Medical Devices | BioSpace

Medical DevicesOctober 23, 2023

SEOUL, South Korea, Oct. 24, 2023 /PRNewswire/ -- RF Medical, specializing in the treatment of tumors and veins with various radiofrequency ablation products, announced today...

How pharmaceutical manufacturers can guarantee a seamless eIFU implementation

Medical DevicesSeptember 22, 2023

Implementing an eIFU-platform is a significant undertaking. But the potential benefits more than making up for this;...

What is a Predetermined Change Control Plan (PCCP) and Who Needs One?

Medical DevicesSeptember 1, 2023

In April 2023, FDA published a new draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device...

Design Controls Implementation

Medical DevicesAugust 30, 2023

Posted by Rob Packard on August 30, 2023 Design controls can be overwhelming, but you can learn the process using this step-by-step...

Regulatory Strategy and the Advantage of Diversity in MedTech

Medical DevicesAugust 17, 2023

In this episode of the Global Medical Device podcast, we discuss the intricate world of medical device regulations, design, and innovation. Hosted live in San...

AMDR Summer 2023 Reprocessing Newsletter

Medical DevicesAugust 2, 2023

NEWS FROM DANFor the second time in less than a...

Integer Holdings Corporation Reports Second Quarter 2023 Results | BioSpace

Medical DevicesJuly 26, 2023

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

15 Questions to Ask QMS Software Vendors in the Medical Device Industry

Medical DevicesJuly 3, 2023

As a medical device company, you are expected to deliver innovative, life-changing medical device(s) while ensuring compliance and achieving true quality. This task bears...

15 Reasons Why Medical Device Companies Choose Greenlight Guru

Medical DevicesJune 22, 2023

MedTech companies are not just companies—they’re innovators building the medical devices that are saving and improving our quality of life. But, bringing life-changing medical...