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What is the eSTAR Pilot Program and How Will it Improve FDA's 510(k) Review Process? - Featured Image

What is the eSTAR Pilot Program and How Will it Improve FDA's 510(k) Review Process?

The FDA announced another new pilot program to improve the consistency and efficiency of its 510(k) ...
How to Choose the Right FDA Regulatory Pathway for your Device - Featured Image

How to Choose the Right FDA Regulatory Pathway for your Device

Most medical device professionals and companies are familiar with Premarket Approval (PMA) and 510(k...
2 Key Areas Missing from FDA CDRH's Regulatory Science Priorities for 2020 - Featured Image

2 Key Areas Missing from FDA CDRH's Regulatory Science Priorities for 2020

What top priorities can medical device professionals and patients expect in 2020 from the Center for...
Navigating the Twists and Turns of Change Management for Medical Devices - Featured Image

Navigating the Twists and Turns of Change Management for Medical Devices

Change is constant… Especially in the medical device industry. Medical device change management can ...
What Is FDA's ASCA Pilot Program And How Does It Impact Medical Device Manufacturers? - Featured Image

What Is FDA's ASCA Pilot Program And How Does It Impact Medical Device Manufacturers?

FDA announced the anticipated 2020 launch of a new pilot program known as the Accreditation Scheme f...
Why Supplier Quality Management Is So Important - Featured Image

Why Supplier Quality Management Is So Important

Effectively managing suppliers, vendors, consultants, and other third party entities that provide pr...
FDA is Expanding its Case for Quality Program... Should Your Company Participate? - Featured Image

FDA is Expanding its Case for Quality Program... Should Your Company Participate?

Depending on the level of quality and compliance, medical devices can impact patients’ lives for bet...
Is FDA's New 'Safer Technologies Program' Applicable To Your Medical Device? - Featured Image

Is FDA's New 'Safer Technologies Program' Applicable To Your Medical Device?

FDA recently announced its new Safer Technologies Program (STeP), which intends to make medical devi...
Understanding the Benefit-Risk Determinations of FDA's Latest Guidance Documents - Featured Image

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

If you haven’t realized it yet, risk management in the medical device industry isn’t going away. How...
Why Design Verification Matters in Medical Device Design and Development - Featured Image

Why Design Verification Matters in Medical Device Design and Development

Design verification can be a difficult stage for medical device companies to carry out effectively. ...
Right-sizing your QMS - Featured Image

Right-sizing your QMS

Is your quality management system (QMS) right-sized to fit with the people, processes and purpose of...
Challenges with Pediatric Medical Devices - Featured Image

Challenges with Pediatric Medical Devices

Challenges continue with the design and development of pediatric medical devices.

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

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