Medical Device Quality, Regulatory and Product Development Blog | Greenlight Guru

Prioritizing Medical Device Reimbursement During Product Development

By Nick Tippmann on February 3, 2021

Medical device reimbursement is a key consideration that must be well researched, understood, and ma...

5 Actionable Lessons Learned from the RADx Initiative by NIH

By Nick Tippmann on January 27, 2021

Rapid Acceleration of Diagnostics (RADx) is an initiative launched by the National Institutes of Hea...

What are the Strategic Priorities for CDRH in 2021?

By Nick Tippmann on January 20, 2021

What are the 2021 strategic priorities for FDA’s Center for Devices and Radiological Health (CDRH) a...

What is the True Cost of Poor Quality for Your Medical Device Company? (Free Infographic)

By Tom Rish on December 1, 2020

For a lot of medical device companies, quality management can be a vexing issue. How much is enough?...

12 Medical Device Experts Offer Best Tips for How to Succeed in 2021

By Jon Speer on November 24, 2020

How will COVID-19, new regulatory programs and changes, and technological advancements impact your m...

Top 100 Medical Device Startups with Most Money Raised in 2020 (Free Chart)

By Nick Tippmann on November 17, 2020

The first half of 2020 brought record-breaking investment totals for health care companies, accordin...

5 Tips for Medical Device Registration across Global Markets

By Jon Speer on August 9, 2020

You have compiled all of the necessary documentation for your regulatory submission, submitted it to...

How Do I Determine if my Product is a Medical Device?

By Jon Speer on August 2, 2020

Let’s say you’re in the medical industry but not yet in the medical device industry. You’re working ...

Protecting the Intellectual Property of your Medical Device Technology

By Nick Tippmann on July 22, 2020

Should you have patent protection for your medical device technology? Should you keep your secret sa...

How to Escape the Lure of Legacy Quality Management Systems

By Jon Speer on July 12, 2020

Many device professionals in small to medium-sized businesses (SMB) still use legacy systems to supp...

How to Build a QMS for a Medical Device

By Nick Tippmann on July 8, 2020

Where do you begin when building a quality management system (QMS) for a medical device? It’s a task...

What is Regulatory Due Diligence for Medical Devices?

By Nick Tippmann on June 24, 2020

What is regulatory due diligence? Why does it matter, and how does it differ from other regulatory s...

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