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

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

By Nick Tippmann on July 12, 2018

Do you know how to use the FDA’s abbreviated 510(k)? Since only 2 percent of 510(k)s have gone the a...

How Priority Designs Used Greenlight Guru to Gain ISO 13485:2016 Certification

By Nick Tippmann on May 25, 2018

We have many different types of companies using Greenlight Guru to help them create a compliant qual...

How SOLIUS Went from Scratch to an eQMS and ISO 13485:2016 Certification