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How to Escape the Lure of Legacy Quality Management Systems - Featured Image

How to Escape the Lure of Legacy Quality Management Systems

Many device professionals in small to medium-sized businesses (SMB) still use legacy systems to supp...
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...
How to Plan and Control the Design of your Medical Device while Meeting Regulatory Expectations - Featured Image

How to Plan and Control the Design of your Medical Device while Meeting Regulatory Expectations

What is the expected process you should follow for your medical device design planning and controls?
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...
4 Emerging Trends in 2020 Backed by Medical Device Industry Experts - Featured Image

4 Emerging Trends in 2020 Backed by Medical Device Industry Experts

Throughout 2020, the medical device industry will see significant changes take flight. Among the big...
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 ...
7 Problems with a Paper-Based Design History File (And How to Avoid Them) - Featured Image

7 Problems with a Paper-Based Design History File (And How to Avoid Them)

If you’re using a paper-based system to manage your design history file (DHF), it can raise several ...
Understanding ISO 14971 Medical Device Risk Management - Featured Image

Understanding ISO 14971 Medical Device Risk Management

Medical device companies MUST have established risk management processes that comply with ISO 14971.

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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