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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
Product Development

Tracking Serious Adverse Events for Medical Devices (to Ensure GCP Compliance)

November 24, 2022
Paragraph 64 of the European Medical Device Regulations (Regulation (EU) 2017/745) states that clinical investigations should follow “well-established international guidance... Read More
Product Development

Developing a Regulatory Strategy

November 23, 2022
What is a regulatory strategy? And for that matter, what do people sometimes think is a regulatory strategy but isn’t? Those are the questions that today’s guest, Mike... Read More
Product Development

What Device Makers Need To Know About Design Verification and Validation

November 21, 2022
Design verification and validation are two essential steps in medical device product development. It’s easy to confuse the two, but there’s a simple way to remember them: Read More

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