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How to Embrace Risk for Safer Devices - Featured Image

How to Embrace Risk for Safer Devices

No matter what you are working on, there are risks involved. Product development is complicated.
Scaling Regulatory and Quality with Your Company - Featured Image

Scaling Regulatory and Quality with Your Company

    Have you thought about your systems and processes related to regulatory and quality standards?
What you need to know About FDA’s Progressive Programs - Featured Image

What you need to know About FDA’s Progressive Programs

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? - Featured Image

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

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)? - Featured Image

What are the regulatory expectations for software as a medical device (SaMD)?

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 - 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?
The Bleeding Edge: Lessons Learned for the Medical Device Industry - Featured Image

The Bleeding Edge: Lessons Learned for the Medical Device Industry

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 - Featured Image

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

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 - Featured Image

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

  It’s time to face facts: a paper-based quality management system is no longer an option.
How Human Factors Impact Your Medical Device - Featured Image

How Human Factors Impact Your Medical Device

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) - Featured Image

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

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 - Featured Image

How to Think About Quality and Regulatory as Your Company Scales

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

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