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Understanding the Benefit-Risk Determinations of FDA's Latest Guidance Documents - Featured Image

Understanding the Benefit-Risk Determinations of FDA's Latest Guidance Documents

By Nick Tippmann on October 2, 2019
If you haven’t realized it yet, risk management in the medical device industry isn’t going away. How...
4 Biggest Challenges in Medical Device Manufacturing (and how to overcome them) - Featured Image

4 Biggest Challenges in Medical Device Manufacturing (and how to overcome them)

By QRA Corp on September 29, 2019
Effective planning is the key to success for any business but to an even greater degree in the medic...
Leveraging Technology and Rapid Prototyping Methodologies during Product Development - Featured Image

Leveraging Technology and Rapid Prototyping Methodologies during Product Development

By Nick Tippmann on September 25, 2019
Do you know everything there is to know about prototyping, product iteration, and manufacturing to g...
Complete Guide to Bringing a Medical Device to Market - Featured Image

Complete Guide to Bringing a Medical Device to Market

By Tom Rish on September 22, 2019
Best Practices for Expediting Your Product Development - Featured Image

Best Practices for Expediting Your Product Development

By Jon Speer on September 15, 2019
Speed to market is one of the major challenges for medical device companies. So, how can you expedit...
Why Design Verification Matters in Medical Device Design and Development - Featured Image

Why Design Verification Matters in Medical Device Design and Development

By Nick Tippmann on September 11, 2019
Design verification can be a difficult stage for medical device companies to carry out effectively. ...
5 Tips from MedTech Executives on the Value of Quality - Featured Image

5 Tips from MedTech Executives on the Value of Quality

By Jon Speer on September 8, 2019
When it comes to making medical devices, quality is key.
Implementing Changes to SaMD under New EU MDR - Featured Image

Implementing Changes to SaMD under New EU MDR

By Nick Tippmann on September 4, 2019
Classification, qualification, and other changes to Software as a Medical Device (SaMD) under the ne...
Career Tips for QA/RA Professionals in the Medical Device Industry - Featured Image

Career Tips for QA/RA Professionals in the Medical Device Industry

By Nick Tippmann on August 28, 2019
Medical device quality and regulatory professionals face changes, challenges, requirements, standard...
Why the FDA Pre-Submission is an Underutilized Tool - Featured Image

Why the FDA Pre-Submission is an Underutilized Tool

By Jon Speer on August 25, 2019
“I wish there was a way for the FDA to give me a feedback about my medical device, prior to submissi...
Right-sizing your QMS - Featured Image

Right-sizing your QMS

By Nick Tippmann on August 21, 2019
Is your quality management system (QMS) right-sized to fit with the people, processes and purpose of...
Photonicare Adopts Medical Device QMS Software to Accelerate Time to Market - Featured Image

Photonicare Adopts Medical Device QMS Software to Accelerate Time to Market

By Nick Tippmann on August 19, 2019

The Greenlight Guru Medical Device Blog

Providing you actionable tips, best practices and insights for better medical device quality, compliance and product development.

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