Medical Device Quality, Regulatory and Product Development Blog

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.

Scaling Regulatory and Quality with Your Company

By Jon Speer on September 2, 2018

Have you thought about your systems and processes related to regulatory and quality standards?

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...

FDA Case for Quality Program: What, Why and How?

By Jon Speer on August 26, 2018

We recently launched a webinar series alongside the FDA, looking at its Case for Quality Program. Th...

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...

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

By Jon Speer on August 19, 2018

Is AI a topic we should be focused on in the medical device industry?

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?

Why Paper-Based Quality Management Systems are No Longer an Option

By Jon Speer on August 12, 2018

It’s time to face facts: a paper-based quality management system is no longer an option.

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...

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