Medical Device Quality, Regulatory and Product Development Blog

Definitive Guide to Change Management for Medical Devices

By Jon Speer on January 22, 2021

In an industry that is ever-evolving, change is inevitable.

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...

Change Management Process Explained in 6 Easy Steps (+ free template)

By Sara Adams on January 19, 2021

In Prosci’s research, participants were six times more likely to meet project goals by following an ...

Say Hello to Predictive Quality: Greenlight Guru Introduces Halo℠ for Change Management

By Nick Tippmann on January 18, 2021

Today’s medical device companies are moving, changing, and adapting at an incredibly rapid pace.

Greenlight Guru Launches Halo℠ For Change Management, World’s First AI & ML Recommendation Engine for Medical Device Quality

By Nick Tippmann on January 18, 2021

New predictive recommendation engine transforms the way medical device companies are able to discove...

Understanding and Handling Different Types of Feedback

By Nick Tippmann on January 14, 2021

What’s the relationship between product feedback, complaints, and adverse events?

How to Use the De Novo Pathway for your Medical Device

By Tom Rish on January 12, 2021

Is the De Novo regulatory pathway a viable option to get your medical device to market?

How to Assess the Impact of Any Change to your Medical Device (+ Free Checklist)

By Jon Speer on January 10, 2021

So you need to make a change to your medical device, what now?

Measuring the Impact of AI/ML Technologies on the Current Medical Device Landscape

By Nick Tippmann on January 6, 2021

What impact has artificial intelligence (AI) and machine learning (ML) had on the medical device ind...

Greenlight Guru and Nelson Labs Announce Strategic Alliance to Mitigate Risk and Guide Customers to Market Faster

By Nick Tippmann on January 5, 2021

Customers benefit from expert advice to lower development costs and save time identifying the right ...

Understanding Change Management and Change Control in the Medical Device Industry

By Taylor Brown on January 4, 2021

Change is inevitable in the medical device industry. Innovative device companies are at the constant...

Post-Pandemic Readiness: Preparing for the Aftermath of COVID-19 on the Medical Device Industry

By Nick Tippmann on December 23, 2020

Are you prepared for the aftermath of the pandemic’s impact on the medical device industry? It may b...

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