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How to Build a QMS for a Medical Device - Featured Image

How to Build a QMS for a Medical Device

Where do you begin when building a quality management system (QMS) for a medical device? It’s a task...
Medical Device Reporting (MDR): How to Take Advantage of Your Electronic Records - Featured Image

Medical Device Reporting (MDR): How to Take Advantage of Your Electronic Records

Some companies in the medical device industry show resistance to digital technology, preferring to u...
The Beginner's Guide to Design Verification and Design Validation for Medical Devices - Featured Image

The Beginner's Guide to Design Verification and Design Validation for Medical Devices

When your medical device product development project gets to Design Verification and Design Validati...
Identifying the Positive and Negative Effects of COVID-19 on the Medical Device Industry - Featured Image

Identifying the Positive and Negative Effects of COVID-19 on the Medical Device Industry

Most of us have read about, observed, participated in, and spoke with healthcare providers and medic...
What you Need to Know about Clinical Evaluation & Validation for Software as a Medical Device (SaMD) - Featured Image

What you Need to Know about Clinical Evaluation & Validation for Software as a Medical Device (SaMD)

Does your software as a medical device (SaMD) function properly? Does it meet the needs of the end u...
What are the Changes to ISO 14971:2019 & TR 24971? - Featured Image

What are the Changes to ISO 14971:2019 & TR 24971?

Proper risk management is a key process throughout the entire life cycle of a medical device. This i...
Only 6% of Device Makers Are Ready for EU MDR — Are You? Here are 3 Ways to Transition Now - Featured Image

Only 6% of Device Makers Are Ready for EU MDR — Are You? Here are 3 Ways to Transition Now

With the deadline for compliance with the EU MDR just around the corner, big changes are being made ...
Understanding Post-Market Surveillance Requirements for Medical Devices (US & EU Markets) - Featured Image

Understanding Post-Market Surveillance Requirements for Medical Devices (US & EU Markets)

As leaders of medical device companies, our goal is always to create devices that are safe and effec...
Best Practices for Expediting Your Product Development - Featured Image

Best Practices for Expediting Your Product Development

Speed to market is one of the major challenges for medical device companies. So, how can you expedit...
5 Myths Engineers Believe About Quality (and what is really true) - Featured Image

5 Myths Engineers Believe About Quality (and what is really true)

A well run medical device company is cross-functional in nature. Engineering, quality, regulatory, m...
AI Explainability: What That Means and Why it Matters in Healthcare - Featured Image

AI Explainability: What That Means and Why it Matters in Healthcare

Is AI a topic we should be focused on in the medical device industry? Artificial Intelligence has ta...
What You Need to Know About Risk Management and Using Post-Market Data - Featured Image

What You Need to Know About Risk Management and Using Post-Market Data

The aim for any medical device company is always to ensure that the devices they make are safe and e...

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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