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4 Biggest Challenges in Medical Device Manufacturing (and how to overcome them) - Featured Image

4 Biggest Challenges in Medical Device Manufacturing (and how to overcome them)

Effective planning is the key to success for any business but to an even greater degree in the medic...
How to Write Effective SOPs for Medical Devices - Featured Image

How to Write Effective SOPs for Medical Devices

Writing and enforcing standard operating procedures (SOPs) for medical devices is required by FDA, I...
5 Most Common Problems with your CAPA Process - Featured Image

5 Most Common Problems with your CAPA Process

Year after year, the corrective and preventive action (CAPA) process continues to be the most widely...
13 Steps to Creating a Risk-Based CAPA Process - Featured Image

13 Steps to Creating a Risk-Based CAPA Process

What does it mean to create a risk-based CAPA process? How should companies go about it?
13 Common Pitfalls to Avoid During Medical Device Product Development - Featured Image

13 Common Pitfalls to Avoid During Medical Device Product Development

Are you falling into some of the common traps that surround medical device product development?
Fundamentals of Supplier Management for Medical Device Companies - Featured Image

Fundamentals of Supplier Management for Medical Device Companies

As a manufacturer of medical devices, it is your responsibility to be on top of the entire system th...
5 Tips for Medical Device Engineers on FDA Design Controls - Featured Image

5 Tips for Medical Device Engineers on FDA Design Controls

If you’re in the medical device industry, you may think that design controls are a confusing imposit...
How To Avoid Being Part of the 69% of 510(k) Submissions That Get Rejected the First Time - Featured Image

How To Avoid Being Part of the 69% of 510(k) Submissions That Get Rejected the First Time

Did you know that 69% of 510(k) submissions were rejected the first time between January and June of...
5 Medical Device Project Management Tips That Will Help You Complete Your Project On Time - Featured Image

5 Medical Device Project Management Tips That Will Help You Complete Your Project On Time

If you’re an engineer at a small medical device company, chances are, at some point, you’re going to...
Why Medical Device Startups Need to Master Juggling and Balancing With Focus - Featured Image

Why Medical Device Startups Need to Master Juggling and Balancing With Focus

Medical device startups are faced with numerous challenges and obstacles to get their products to ma...
How To Navigate the Difficult Road of Medical Device Product Development While Avoiding the Common Pitfalls - Featured Image

How To Navigate the Difficult Road of Medical Device Product Development While Avoiding the Common Pitfalls

Click here to enlarge image. The story I’m about to tell you is about Eddy Engineer and his trials a...
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. 

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