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4 Medical Device Quality System Musts for Startups - Featured Image

4 Medical Device Quality System Musts for Startups

Medical device startups have a pile of things to address yet often don’t have the pile of money to t...
Understanding Risk in Medical Device New Product Development (NPD) - Featured Image

Understanding Risk in Medical Device New Product Development (NPD)

New product development (NPD) consists of workflow, decision and information flow across multiple fu...
6 Medical Device Product Development Steps To Fast-Track Your Path To Market - Featured Image

6 Medical Device Product Development Steps To Fast-Track Your Path To Market

This article originally appeared as a guest expert post on Med Device Online. Congratulations! You h...
Why FMEA is Not ISO 14971 Risk Management - Featured Image

Why FMEA is Not ISO 14971 Risk Management

If you are still using FMEA as your methodology to capture medical device risk management activities...
4 Reasons Why Your Risk Management Approach is Wrong - Featured Image

4 Reasons Why Your Risk Management Approach is Wrong

This article originally appeared as a guest post on MedTech Intelligence. A few months ago, I predic...
The Risk Management + Design Controls Connection: What Device Makers Need to Know - Featured Image

The Risk Management + Design Controls Connection: What Device Makers Need to Know

Part 1: Intended Use & User Needs Medical devices are intended to save and improve quality of life. 
Why Getting FDA 510(k) Clearance Alone is Not Enough (And 6 Things You Can Do About It) - Featured Image

Why Getting FDA 510(k) Clearance Alone is Not Enough (And 6 Things You Can Do About It)

Getting FDA 510(k) market clearance is a significant, meaningful milestone and achievement for any m...
5 Reasons Why You Need To Implement a QMS or Bust - Featured Image

5 Reasons Why You Need To Implement a QMS or Bust

Look, I get it. Worrying about implementing a quality management system isn't on your list of the to...
How To Identify, Quantify and Manage Enterprise Risks for Medical Device Companies with Mike Cremeans - Featured Image

How To Identify, Quantify and Manage Enterprise Risks for Medical Device Companies with Mike Cremeans

In episode #9 of the Global Medical Device Podcast we’re joined by Mike Cremeans. Mike is the Vice P...
15 Items Medical Device Startups Need to Address - Featured Image

15 Items Medical Device Startups Need to Address

As a medical device startup, there are many things you are juggling and balancing all day, every day...
The Many Connotations Of Risk In Medtech Development — And The Consequences Of Getting Them Wrong - Featured Image

The Many Connotations Of Risk In Medtech Development — And The Consequences Of Getting Them Wrong

Risk assessment and risk management in the medical device industry typically start with a brainstorm...
Risk Management from a Regulatory & Product Development Perspective [Podcast] - Featured Image

Risk Management from a Regulatory & Product Development Perspective [Podcast]

Risk management for medical devices from a regulatory and product development perspective is the top...

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