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ramosstarnesprojec
Apr 3, 20246 min read
QMS: Purchasing Controls
Hello everyone and welcome back to another week of MedTech Compliance Chronicles! This week we are continuing our exploration of the...
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ramosstarnesprojec
Mar 27, 20246 min read
QMS: Design & Development
Hello all and welcome back to MedTech Compliance Chronicles. Following the previous two week’s posts about the requirements for planning...
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ramosstarnesprojec
Mar 20, 20246 min read
QMS: Risk Management
Good day to all and welcome back to another week of MedTech Compliance Chronicles! This week we focus on one of the most core,...
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ramosstarnesprojec
Mar 13, 20244 min read
QMS: Planning for Product Realization
Welcome back to MedTech Compliance Chronicles! Continuing our journey through the Quality Management System (QMS), we shift our focus...
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ramosstarnesprojec
Feb 27, 20245 min read
QMS: Resource Management
Good day to all and welcome back to another week of MedTech Compliance Chronicles. Last week we spoke about management responsibilities...
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ramosstarnesprojec
Feb 20, 20246 min read
QMS: Management Responsibility
Hello all and welcome to another week of MedTech Compliance Chronicles. After a couple weeks of setting the foundations of the QMS we are...
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ramosstarnesprojec
Feb 13, 20245 min read
QMS: Document Control
Good day to all and welcome back to another week of MedTech Compliance Chronicles. This week our topic is document control. It was a...
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ramosstarnesprojec
Feb 6, 20245 min read
QMS: Process Approach
Hello and welcome to another week of MedTech Compliance Chronicles! Last week we learned about what a Quality Management System (QMS) is...
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ramosstarnesprojec
Jan 30, 20245 min read
Introducing the Quality Management System
Welcome to week 4 of MedTech Compliance Chronicles! This week is a special one. Today’s post will be the first in a series about...
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ramosstarnesprojec
Jan 23, 20243 min read
Classifying Your Medical Device
Hello everyone and welcome back to MedTech Compliance Chronicles. Last week we took a pretty detailed look into how the US FDA classifies...
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ramosstarnesprojec
Jan 16, 20245 min read
How the FDA Classifies Medical Devices
Hello everyone and welcome back to MedTech Compliance Chronicles. Now that we have determined our product is a medical device the next...
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ramosstarnesprojec
Jan 7, 20246 min read
MedTech Compliance Chronicles: Navigating FDA Regulations
Is your product a Medical Device? Good evening to all and welcome to the MedTech Compliance Chronicles: Navigating FDA Regulations blog....
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