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Product Development

Ultimate Guide to Device Class Requirements under EU MDR

September 19, 2023
Marketing a device in the European market means complying with the numerous safety and technical requirements of the Medical Device Regulation (MDR). In practice, this can be... Read More
Regulatory Submission

Accelerating SaMD Development in a Compliant Agile Way

September 7, 2023
In this episode, we explore the impact of software development methodologies in the medical device industry. Read More
Regulatory Submission

MedTech Funding and Preparing for Due Diligence

August 31, 2023
Join guest Devon Campbell as we discuss MedTech funding in this episode of the Global Medical Device Podcast. He unveils startup red flags, from data integrity to product... Read More
Regulatory Submission

Exploring Breakthrough Device Designation

August 25, 2023
In this episode of the Global Medical Device Podcast, Etienne Nichols and Ellie Reynolds explore FDA's Breakthrough Device designation. Read More
Post-Market Surveillance

How to Comply with HIPAA and EU GDPR in Medical Device Studies

August 17, 2023
The U.N. recognizes privacy as a fundamental human right, and nowhere is this more important than in medical data. That’s why both the US and the EU have regulations in place... Read More
Establishing a QMS

Conducting Quality Investigations in Medical Device Manufacturing

August 11, 2023
When a quality event, like a product or process nonconformance, occurs in the manufacturing of medical devices, there’s a chance that the safety and efficacy of any affected... Read More
Establishing a QMS

Omnibus Act Impact on Medical Device Cybersecurity

August 7, 2023
The ‘‘Consolidated Appropriations Act, 2023’’ (H.R. 2617) was passed by the U.S. Senate and signed into law by President Biden on December 29, 2022. Read More
Post-Market Surveillance

Boost Efficiency and Decision-Making with Enhanced Clinical Data Reporting

August 4, 2023
The latest SMART-TRIAL by Greenlight Guru update includes a newly designed Reporting module that streamlines clinical data management for scaling medical device companies. By... Read More
Establishing a QMS

QMSR Explained: What FDA QSR & ISO 13485 Harmonization Means for Medical Device Companies

July 21, 2023
On February 23, 2022, FDA released its proposed rule for the new Quality Management System Regulation (QMSR). Read More

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