Medical Device Quality, Regulatory and Product Development Blog | Greenlight Guru

How to Embrace Risk for Safer Devices

By Nick Tippmann on September 5, 2018

No matter what you are working on, there are risks involved. Product development is complicated.

What you need to know About FDA’s Progressive Programs

By Nick Tippmann on August 29, 2018

Are you familiar with FDA’s progressive programs for medical device companies? Do you know about Exp...

What Are the Regulatory Expectations for Software as a Medical Device (SaMD)?

By Nick Tippmann on August 22, 2018

These days, medical devices often include software or are standalone software. So, software as a med...

The Bleeding Edge: Lessons Learned for the Medical Device Industry

By Nick Tippmann on August 17, 2018

Sometimes, do things make you go, “Hhhmmmm…” Jon Speer recently watched a documentary about the medi...

AI Explainability: What that Means and Why it Matters in the Medical Device Industry

By Nick Tippmann on August 14, 2018

Is artificial intelligence (AI) a topic that should be focused on in the medical device industry?

How Human Factors Impact Your Medical Device

By Nick Tippmann on August 8, 2018

Human factors can be a tricky topic that creates confusion, especially when it comes to medical devi...

Medical Device Companies - Top 100 in 2018 (Free Chart)

By Nick Tippmann on August 5, 2018

Have you ever wondered about the biggest medical device companies in the world? Maybe you're looking...

How to Think About Quality and Regulatory as Your Company Scales

By Nick Tippmann on August 1, 2018

As companies transition from being a start-up or small company to a more established business and br...

How to Design for Compliance with IEC60601

By Nick Tippmann on July 25, 2018

Have you ever designed a medical device that has electrical components? Was it frustrating to go thr...

FDA Proposes Allowing Medical Device Makers to Summarize Malfunctions: What does that Mean for You?

By Nick Tippmann on July 18, 2018

The FDA announced a new proposal regarding the bundling of device malfunctions when Medical Device R...

Why There is a Need for Multi-Level Design Controls

By Nick Tippmann on July 12, 2018

We’ve added an exciting new update to our platform recently. The ability to manage multi-level desig...

How to Use the Abbreviated FDA 510(k) Pathway to Your Advantage