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Building a Culture of Quality - Featured Image

Building a Culture of Quality

How do you build a company that puts culture before function? Results before profit? Building a cult...
Quality Assurance vs. Quality Control in the Medical Device Industry - Featured Image

Quality Assurance vs. Quality Control in the Medical Device Industry

Imagine that your medical device malfunctioned during patient use. Do you know whether quality assur...
Bringing Medical Devices Into The Home - Featured Image

Bringing Medical Devices Into The Home

Are you passionate about human-centered design and how it relates to health care? Patients deserve a...
How to Build a Medical Device Business Case in 5 Easy Steps - Featured Image

How to Build a Medical Device Business Case in 5 Easy Steps

In business, so much of success depends on timing. A product launches too early and is misunderstood...
Demystifying the De Novo Process - Featured Image

Demystifying the De Novo Process

How do you navigate the De Novo process for your medical device? When do you decide to go that route...
Challenges for Regulatory Submission: EU vs. US - Featured Image

Challenges for Regulatory Submission: EU vs. US

What are the regulatory pathways used in the United States versus the European Union (EU)? Dealing w...
8 Questions That Define Your Medical Device User Needs - Featured Image

8 Questions That Define Your Medical Device User Needs

When people talk about design controls, they often place a lot of emphasis on design inputs and outp...
Performance Evaluation Under EU IVDR: Proving Your IVD’s Performance - Featured Image

Performance Evaluation Under EU IVDR: Proving Your IVD’s Performance

A Performance Evaluation (PE) is required for any in vitro diagnostic device (IVD) that a manufactur...
From Startup to Industry Leader: LIVE RECORDING AT SCBIO CONFERENCE - Featured Image

From Startup to Industry Leader: LIVE RECORDING AT SCBIO CONFERENCE

Have you ever played the game, Operation? The patient’s nose would light up and buzz if your tweezer...
30/60/90 Day Plan to Making an Impact as a New QA/RA Manager - Featured Image

30/60/90 Day Plan to Making an Impact as a New QA/RA Manager

Starting a new job is always a little stressful. But when you’re a new QA/RA Manager, there’s even m...
The Future of Cybersecurity - Featured Image

The Future of Cybersecurity

What will the future be for software as a medical device (SaMD) and cybersecurity? Manufacturers nee...
Post-Market Clinical Follow-up Under EU MDR: Your Guide to PMCF Activities - Featured Image

Post-Market Clinical Follow-up Under EU MDR: Your Guide to PMCF Activities

The post-market clinical follow-up (PMCF) is one of several forms of post-market surveillance stipul...

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Providing you actionable tips, best practices and insights for better medical device quality, compliance and product development.

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