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7 Habits of Highly Effective True Quality Medical Device Professionals - Featured Image

7 Habits of Highly Effective True Quality Medical Device Professionals

What is true quality? How do you achieve it?
Questions to Ask Before Hiring Your QA/RA Consultant - Featured Image

Questions to Ask Before Hiring Your QA/RA Consultant

Do you work with regulatory consultants to implement a quality system or 510(k), or perform other ta...
What You Need to Know About The FDA CDRH Experiential Learning Program - Featured Image

What You Need to Know About The FDA CDRH Experiential Learning Program

FDA has a new program called, The Experiential Learning Program, which involves CDRH going to medica...
Latest Updates on CDRH Standards Program and IEC 60601 - Featured Image

Latest Updates on CDRH Standards Program and IEC 60601

Medical device standards seem to change and evolve all the time. Is it impossible to keep up with th...
15 Habits of Highly Effective Regulatory Professionals - Featured Image

15 Habits of Highly Effective Regulatory Professionals

Quality and regulatory professionals in the medical device industry have to deal with a lot. In this...
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.
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...
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...
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?
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...
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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