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

3 FAQ about CE Marking Medical Device Manufacturers Want to Know

By Etienne Nichols on October 10, 2021

If you take a close look at many of the objects you use each day—keyboards, monitors, headphones, an...

Creating a Quality Manual That Complies with ISO 13485

By Taylor Brown on October 3, 2021

An excellent quality management system (QMS) is one of the keys to bringing a safe and effective med...

How to Execute a Successful Product Launch

By Jon Speer on September 26, 2021

Bringing a medical device to market can take anywhere from three to seven years, on average. The des...

3 Medical Device Reimbursement Strategies to Recoup Your Investment in the US

By Tom Rish on September 19, 2021

Anyone who works in the medical device industry will tell you that quality and patient care is of th...

Why Demand is so High for Regulatory & Quality Jobs (and should you take advantage?)

By Nick Tippmann on May 12, 2021

Great uncertainty brings great opportunities for growth...career growth. Currently, regulatory roles...

Managing Business Risk as a Medical Device Company

By Nick Tippmann on May 3, 2021

It's easy to get so wrapped up in the risk management of your medical device that you forget about m...

Waterfall vs. Agile: Battle of the Product Development Methodologies

By Nick Tippmann on April 28, 2021

Are you 'Team Waterfall' or 'Team Agile' for your product development methodology of choice?

Pivoting Operations to Meet PPE Demand during Pandemic

By Nick Tippmann on April 14, 2021

Are you on the frontlines of developing new medical devices and technologies during COVID-19? Or, ar...

Pros & Cons of Being a Physician turned MedTech Inventor

By Nick Tippmann on April 13, 2021

Do you fear needles and the associated pain? No one understands this fear more than physicians who s...

Learning about the Real-world Impact of Design, Manufacturing, Quality & Culture on Patients

By Nick Tippmann on March 24, 2021

Why is design, manufacturing, quality, and culture so important in the medical device industry?

3 Valuable Outcomes of a Culture of Quality

By Jon Speer on March 21, 2021

Do you consider your medical device company to have a culture of quality?

Building a Startup in the MedTech Industry

By Nick Tippmann on March 10, 2021

What does it take to build a successful MedTech startup? It’s a multi-million dollar question and th...

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