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Product Development

Ultimate Guide to Device Class Requirements under EU MDR

December 11, 2022
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
Product Development

Electronic Data Capture for Medical Devices: Then vs. Now

December 9, 2022
Decades ago, data from clinical trials could only be captured using paper Case Report Forms (CRFs). Researchers would fill out the CRFs by hand at the site of the clinical... Read More
Product Development

How to Use SMART-TRIAL by Greenlight Guru's ePRO Module

December 9, 2022
SMART-TRIAL by Greenlight Guru is the only MedTech specific electronic data capture (EDC) system. One of the first features built into our EDC system was an integrated e-mail... Read More
MedTech Lifecycle Excellence

Greenlight Guru Appoints Dan Thompson as Chief Sales Officer and Jeff Perkins as Chief Marketing Officer

December 8, 2022
The company adds two experienced executives to help accelerate growth and global expansion. Read More
Product Development

The Future of Healthcare & How We Get There

December 7, 2022
What kinds of possibilities exist in the future for healthcare? How can medical devices reach across different fields of medicine and provide a holistic patient... Read More
Product Development

How ePRO Can Help Comply with EU MDR Post-Market Surveillance

December 5, 2022
The EU MDR places more focus on Post-Market Surveillance (PMS) and clinical data collection. Since the EU MDR came into force, medical device manufacturers need to keep... Read More
Product Development

The Difference Between Intended Use and Indications of Use (And Why These Statements Are So Important)

December 2, 2022
“Intended use” and “indications for use” are two of the easiest terms to confuse in the medical device industry. They’re often used interchangeably, not only because they... Read More
Product Development

Nonconformance (NC) and CAPA: When Should You Use Each Process?

December 2, 2022
Your nonconformance (NC) and Corrective Action and Preventive Action (CAPA) processes are two critical elements within your quality management system. Read More
Product Development

What "Exempt" Means with Respect to Medical Devices & Regulatory

November 30, 2022
How should you be thinking about 510(k) exemptions for medical devices? Do you know when things do and don’t qualify for exemption and how that intersects with how a... Read More

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